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28Jul2021

Business and trading update - July 2021

12Jul2021

Diurnal receives Special Protocol Assessment Agreement for Chronocort® from the FDA

Pivotal Phase 3 trial expected to commence in the US in H2 2021 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today announces that the US Food and Drug Administration (FDA) has agreed a Special Protocol Assessment (SPA) for Chronocort® (modified-release hydrocortisone) for the design, endpoints and statistical analysis approach of a pivotal study of Chronocort® for the treatment for Congenital Adrenal Hyperplasia (CAH) in the US. The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that would support the regulatory submission for drug approval. The pivotal study is entitled “A randomised, double-blind, active-controlled, Phase 3 study of Chronocort® compared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with Congenital Adrenal Hyperplasia (CAH)” – CONnECT – and is anticipated to start during H2 2021. Study start-up activities have already been commenced by the Company to enable a timely initiation and recruitment of up to 150 subjects with CAH who will be treated for a period of 52 weeks. Chronocort® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition, caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. Diurnal holds the relevant Orphan Drug Designation for use of Chronocort® in CAH in the US. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 16,000 patients in the US. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are pleased to have concluded a series of positive discussions with the FDA around the design of our pivotal Chronocort® study to support a regulatory submission for marketing approval in the US. During the first half of 2021 the Diurnal team has been working hard to complete the required preparation activities for this trial and we look forward to starting this study as soon as possible.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About the FDA’s Special Protocol Assistance The SPA process documents the FDA’s official evaluation and written guidance on the design and size of proposed protocols and agreement that the design and planned analysis of a study can adequately address objectives in support of a regulatory submission. Final determinations for marketing application approval, however, are made after a complete review of a marketing application and are based on the entire data in the application. The agreed SPA may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety. About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect approximately 16,000 patients in the US, with over 400,000 in the rest of the world. About Chronocort® (modified-release hydrocortisone) Chronocort ®  is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first planned indication for Chronocort  ®  in the US is Congenital Adrenal Hyperplasia (CAH) in adults and children older than 16 years of age. Chronocort  ®  has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. Although Chronocort® is still an investigational product in the US, Chronocort® (known in Europe as Efmody®) has already achieved marketing authorisation approval from the European Commission (in the European Economic Area) and the Medicines and Healthcare products Regulatory Agency (in Great Britain). These marketing authorisations for Efmody® are based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, including a site in the US, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody® over an extended period, with a number of patients on this trial having been treated for over 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody® treatment. The human medicine European public assessment report (EPAR) for Efmody® can be viewed  null  and the Summary of Product Characteristics (SmPC)  null About Diurnal Group plc Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null Date of Preparation: July 2021               Code: CORP-GB-0141

02Jul2021

Diurnal receives Marketing Authorisation for Efmody® in Great Britain from the MHRA

Efmody® provides a new treatment option for c.5,000 patients suffering from CAH in GB GB launch of Efmody® expected in Q1 2022 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a Marketing Authorisation for Efmody® (hydrocortisone modified-release hard capsules – development name Chronocort®) as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH). The Marketing Authorisation for Efmody® from the MHRA applies in Great Britain (England, Wales and Scotland) and follows the recent approval of the product in the European Economic Area (including Northern Ireland)(EEA) by the European Commission as announced on 28 May 2021. The submission to the MHRA included detailed analysis of data from the Company's Phase 3 study, the largest ever completed interventional clinical trial in CAH involving 122 subjects, and an open-label safety extension study of Efmody®. To facilitate timely commercial availability, Diurnal has already commenced market access activities in Great Britain, with the commercial launch anticipated in Q1 2022. The Company intends to mirror its strategy for Alkindi® (hydrocortisone granules in capsules for opening) by commercialising the product itself in Great Britain as well as other core European markets. Following feedback from the MHRA and consistent with the approach taken in the EEA, the Company has decided not to pursue Orphan Drug Status for Efmody® in Great Britain as it would likely cause a significant delay to the commercial launch. Whilst Orphan Designation provides market exclusivity for 10 years from launch, the Company currently holds granted patents for Efmody® for the treatment of patients with CAH and believes these patents provide sufficient protection for Efmody® until at least 2033 in Great Britain. Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 5,000 patients in Great Britain. Professor Wiebke Arlt, Institute of Metabolism and Systems Research, University of Birmingham, commented: “I am excited to see Efmody® approved in Great Britain as a treatment for patients with CAH, a rare condition where patients and doctors need to face the challenge of deficient cortisol production and adrenal androgen excess. Efmody® has been developed for these patients and I believe this drug approval provides a new option for the treatment of CAH patients, where there is a significant unmet medical need.” Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are pleased to have received approval for Efmody® from the MHRA and look forward to making Efmody® available to CAH patients in Great Britain as the first licensed treatment specifically designed to mimic the physiological circadian rhythm of cortisol. Today’s approval is yet another important step forward for Diurnal as we continue to drive towards becoming the world’s leading specialty endocrinology business.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is a rare condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe and Great Britain, with over 400,000 in the rest of the world. About Efmody® (hydrocortisone modified-release hard capsules) Efmody ® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody ® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody ® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The MHRA and European Commission marketing authorisation approval of Efmody® is based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, including sites in Great Britain, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody® over an extended period, with a number of patients on this trial having been treated for over 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody® treatment. Summary of Product Characteristics (SmPC) for UK (Northern Ireland) can be found null . About Diurnal Group plc Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit null Date of Preparation: July 2021               Code: CORP-GB-0137

29Jun2021

Distribution agreement with Er-Kim for Bulgaria and Romania

Extends relationship with Er-Kim following Turkey agreement for Alkindi ® and Efmody® Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has extended its distribution arrangements with Er-Kim, a leading partner for global biotech and pharma companies seeking to commercialise its products in Turkey, Europe and the Middle East, to include the distribution and marketing of Alkindi® (hydrocortisone granules in capsules for opening) and Efmody® (hydrocortisone modified-release hard capsules) in Bulgaria and Romania. Under the terms of the agreement, Er-Kim will receive the exclusive rights to distribute and market Alkindi® and Efmody® in Bulgaria and Romania. The combined market in both countries is estimated to be more than $13m in paediatric adrenal insufficiency (AI) and adult congenital adrenal hyperplasia (CAH). Alkindi® already has marketing authorisation in the European Union and is the first preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from AI, including the related condition CAH. Efmody® is a modified-release preparation of hydrocortisone for the treatment of patients with CAH, a rare condition caused by a genetic deficiency of adrenal enzymes. In May 2021, Efmody® was granted marketing authorisation in the European Union and, to facilitate timely commercial availability, the Company has commenced market access activities with commercial launches in European countries anticipated to commence from Q3 2021. In line with the Company’s other global distribution agreements, Diurnal will provide Alkindi® and Efmody® from its established European supply chain for sale by Er-Kim. This agreement adds to the Company's ongoing strategy for commercialisation of its lead products by optimising market access outside of the larger European markets, where Diurnal directly markets its products, through entering marketing and distribution agreements with companies focused on niche and orphan conditions. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are pleased to announce the extension of our relationship with Er-Kim to make our products, Alkindi® and Efmody®, available to patients with diseases of cortisol deficiency in Bulgaria and Romania. As Efmody® becomes available for patients in Europe from Q3 2021, this agreement is in line with our strategy to optimise global market access for our products. Since signing our initial agreement with Er-Kim in January 2021 for Turkey, we have been impressed with Er-Kim’s in-market expertise and with a strong track record of commercialisation, we look forward to strengthening this relationship going forward.” Cem Zorlular, Chairman and Chief Executive Officer of Er-Kim, commented: “We are incredibly motivated by the prospect of enabling access for patients in Bulgaria and Romania to Diurnal’s much needed pediatric and adult cortisol deficiency treatments. Furthermore, we feel privileged to expand our collaboration with Diurnal who share our passion in addressing patients’ unmet needs in rare and chronic endocrine conditions.” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About paediatric adrenal insufficiency Paediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone). About Alkindi® (hydrocortisone granules in capsules for opening) Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH). Alkindi ® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including paediatric AI and CAH. AI requires life-long treatment and Diurnal's novel approach to product development has the potential to significantly improve these young patients' lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is approved and known as Alkindi ® Sprinkle in the US where it is licensed and marketed by Eton Pharmaceuticals. Alkindi® is also approved in Israel and Australia. The human medicine European public assessment report (EPAR) for Alkindi® can be viewed  null and the Summary of Product Characteristics (SmPC)  null . About congenital adrenal hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 400,000 patients worldwide. About Efmody® (hydrocortisone modified-release hard capsules) Efmody ®  is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody ®  is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody ®  has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The European Commission market authorisation of Efmody® is based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody ® over an extended period, with a number of patients on this trial having been treated for over 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody® treatment. The human medicine European public assessment report (EPAR) for Efmody® can be viewed  null  and the Summary of Product Characteristics (SmPC)  null . About Diurnal Group plc Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null About Er-Kim Er-Kim is a leading commercial partner for global biotech and pharma companies seeking to commercialise its products in Turkey, Europe and Middle East. In its 40-year of presence, Er-Kim has commercialised over 150 original therapies from more than 50 leading global pharmaceutical companies. Additionally, Er-Kim operates in drug discovery for unmet needs in rare blood diseases and R&D providing cost-effective manufacturing of advanced medicinal products easing the economic burden of the healthcare system. For further information about Er-Kim, please visit  null Date of Preparation: June 2021 Code: CORP-GB-0133

01Jun2021

Diurnal triggers $1.25m in milestone payments from Citrine Medicine

Diurnal triggers $1.25m in milestone payments from Citrine Medicine Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has triggered payments totalling $1.25 million from Citrine Medicine, Inc. (“Citrine”), its partner in China, relating to the recent European Commission’s (EC) approval for Efmody® (hydrocortisone modified-release hard capsules) and the attainment by Citrine of certain development milestones in China for Alkindi®(hydrocortisone granules in capsules for opening). Citrine continues to plan for a New Drug Application (NDA) submission to the National Medical Products Administration in 2021 for Alkindi®. Citrine is a therapeutics platform company focused on the Greater China market that has licensed the registration and commercialisation rights for Alkindi® and Efmody®in China, Hong Kong, Taiwan and Macau. Today’s announcement follows the Company extending its exclusive license agreement with Citrine in May 2021 to cover Efmody® and subsequently receiving an upfront payment of $1.0 million. This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About Congenital AdrenalHyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 400,000 patients worldwide.   About Alkindi®(hydrocortisone granules in capsules for opening) Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including paediatric AI and CAH. AI requires life-long treatment and Diurnal's novel approach to product development has the potential to significantly improve these young patients' lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is approved and known as Alkindi® Sprinkle in the US where it is licensed and marketed by Eton Pharmaceuticals. Alkindi® is also approved in Israel and Australia. About Efmody®(hydrocortisone modified-release hard capsules) Efmody® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The EC registration of Efmody is based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody® over an extended period, with a number of patients on this trial having been treated for over 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody® treatment. About Diurnal Group plc Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit null About Citrine Medicine Citrine Medicine is dedicated to improving the lives of patients with rare and intractable diseases by making diagnosis and essential treatments available and accessible to those who need them in China. Our mission is to build the first rare disease ecosystem in China and in doing so, enable people with rare diseases to live more normal lives. In addition to developing and marketing rare disease drugs, Citrine aims to establish a patient-centric platform which educates people on rare diseases, trains doctors on diagnosis and treatment, and helps doctors develop a full disease management protocol. Citrine's lead product candidate, Wakix® (pitolisant), is an investigational oral drug in development for the treatment of narcolepsy and obstructive sleep apnea in China. Citrine has initiated an Investigational New Drug (IND) submission for pitolisant in the treatment of narcolepsy and expects to complete the IND submission in the first quarter of 2021. Citrine also recently announced a strategic partnership that will allow the company exclusive rights to develop, register, and commercialize Alkindi® - the first clinically validated pediatric treatment for congenital adrenal hyperplasia – in the Greater China market. Citrine is headquartered in Shanghai and has other offices in Beijing, China and Cambridge, Mass. For further information about Citrine Medicine, please visit null Date of Preparation: June 2021              Code: CORP-GB-0127

28May2021

Diurnal receives European Commission approval for Efmody®

First licensed treatment for European patients with CAH that mimics the physiological circadian rhythm of cortisol Diurnal’s second product to receive marketing authorisation Commercial launch anticipated in Q3 2021 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces the European Commission (EC) has approved the marketing authorisation for Efmody® (hydrocortisone modified-release hard capsules – development name Chronocort®) as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH). This decision by the EC follows the positive opinion issued by the European Medicines Agency (EMA) in March 2021. To facilitate timely commercial availability, Diurnal has already commenced market access activities in its target European territories, with the first commercial launch anticipated in Q3 2021. The Company intends to mirror its strategy for Alkindi® (hydrocortisone granules in capsules for opening) by commercialising the product itself in core European markets. The EC decision for Efmody® is valid in all countries of the European Union, and will also be adopted by Norway, Iceland and Liechtenstein. Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 36,000 in the European Economic Area. Professor Dr med Nicole Reisch, Professor of Internal Medicine, Endocrinology at the Ludwig-Maximilian-University Munich, commented: “We welcome today’s decision by the European Commission for Efmody ® as treatment for adult and adolescent patients with the rare disease of congenital adrenal hyperplasia. Efmody® has been proven to provide control of the disease and the overall data shows an improved hormone balance, which will provide a well-tolerated and practical twice-daily treatment regimen for these patients where there is a significant unmet need. As the first licensed treatment for European patients with congenital adrenal hyperplasia that mimics the physiological circadian rhythm of cortisol, we look forward to having an additional therapeutic option for congenital adrenal hyperplasia patients in the near future.” Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are delighted to have received European approval for Efmody ®, a significant milestone for Diurnal as our second product to receive marketing authorisation. We look forward to expanding our adrenal portfolio with the European launch of Efmody® in Q3 2021 alongside our first product Alkindi®, to provide treatment for patients with congenital adrenal hyperplasia, enabling Diurnal to continue to drive towards becoming a world-leading specialty endocrinology business. ” This is a business press release containing financial information and/or data for the benefit of shareholders and potential investors. Data are included to allow informed investment decisions. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe and the United Kingdom, with over 400,000 in the rest of the world. About Efmody® (hydrocortisone modified release hard capsules) Efmody ®  is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody ®  is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody ®  has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The European Commission approval of Efmody® is based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody® over an extended period, with a number of patients on this trial having been treated for over 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody® treatment. About Diurnal Group plc Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null Date of Preparation: May 2021 Code: CORP-GB-0119 View pdf of document: null

12May2021

China licensing agreement with Citrine Medicine for Efmody®

Partnership extended with China-based rare disease therapeutics company Total up-front payment and future milestones of up to $29.75 million, with double-digit royalties on sales Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces it has extended its exclusive licence agreement with the specialty pharmaceutical company, Citrine Medicine, Inc. (“Citrine”), to include the registration, distribution and marketing of Efmody® (hydrocortisone modified-release hard capsules – development name Chronocort®) covering China, Hong Kong, Taiwan and Macau. Under the terms of the licence agreement, Diurnal will receive a non-refundable upfront payment of $1.0 million and will receive $28.75 million in additional cash payments upon achievement of certain regulatory milestones and sales milestones based on annual sales thresholds. Diurnal will also receive tiered royalties on sales ranging from low to mid double-digits. Citrine is a therapeutics platform company focused on the Greater China market that was co-founded by Vivo Capital, F-Prime Capital and Eight Roads Ventures. Citrine is focused on creating a therapeutic platform to deliver rare disease drugs to the Chinese market and to develop the first ever rare disease ecosystem in the country. The Company signed an original licensing agreement with Citrine in January 2021 for obtaining registration for Alkindi® (hydrocortisone granules in capsules for opening) as well as for all commercialisation activities in China. Citrine will be responsible for obtaining registration for Efmody ® as treatment of patients with the rare conditions congenital adrenal hyperplasia (CAH) and adrenal insufficiency (AI) in China and for all commercialisation activities, including pricing and reimbursement. Citrine will initially utilise product from Diurnal’s European supply chain, with an option to establish its own supply chain in China in the future. It is estimated that CAH occurs in 1 in 6,084 births in China 1. CAH is a group of genetic conditions that limit hormone production in the adrenal glands and was identified a rare disease by the Chinese health authorities in May 2018. Martin Whitaker, CEO of Diurnal, commented: “We are pleased to expand our partnership with Citrine in China to include both of our lead cortisol deficiency products. We have been impressed by Citrine’s local development, regulatory and commercialisation expertise for Alkindi® and look forward to this knowledge and experience being applied to Efmody®. Following the recent positive CHMP opinion received for Efmody ® in Europe, this licensing agreement is in line with our strategy to optimise market access of our products outside of key European markets. If approved, Efmody® will provide a major breakthrough in China as the first licensed treatment for Chinese patients with CAH, that mimics the physiological circadian rhythm of cortisol , where there is a significant unmet patient need.” Melissa Bradford-Klug, President and Chief Business Officer of Citrine, commented: “It is with much excitement that we extend our licensing agreement with Diurnal, which will ultimately enable us to serve the needs of Chinese patients of all ages suffering from CAH. The team at Diurnal are great partners and we look forward to continuing to work with them as we bring both Alkindi® and Efmody® through the regulatory approval process in China.” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). 1 Zhong, K. et al. (2016) ‘The status of neonatal screening in China, 2013’, Journal of Medical Screening, 23(2), pp. 59–61. doi: 10.1177/0969141315597715. For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Alex Davis Notes to Editors About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe, with over 400,000 in the rest of the world. About Efmody® (hydrocortisone modified-release hard capsules) Efmody® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The positive opinion from the CHMP received in March 2021 is based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody ® over an extended period, with a number of patients on this trial having been treated for over 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody® treatment. About Diurnal Group plc Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null About Citrine Medicine Citrine Medicine is dedicated to improving the lives of patients with rare and intractable diseases by making diagnosis and essential treatments available and accessible to those who need them in China. Our mission is to build the first rare disease ecosystem in China and in doing so, enable people with rare diseases to live more normal lives. In addition to developing and marketing rare disease drugs, Citrine aims to establish a patient-centric platform which educates people on rare diseases, trains doctors on diagnosis and treatment, and helps doctors develop a full disease management protocol. Citrine's lead product candidate, Wakix ® (pitolisant), is an investigational oral drug in development for the treatment of narcolepsy and obstructive sleep apnea in China. Citrine has initiated an Investigational New Drug (IND) submission for pitolisant in the treatment of narcolepsy and expects to complete the IND submission in the first quarter of 2021. Citrine also recently announced a strategic partnership that will allow the company exclusive rights to develop, register, and commercialize Alkindi® - the first clinically validated pediatric treatment for congenital adrenal hyperplasia – in the Greater China market. Citrine is headquartered in Shanghai and has other offices in Beijing, China and Cambridge, Mass. For further information about Citrine Medicine, please visit  null Date of Preparation: May 2021 Code: CORP-GB-0120 View pdf document: null

23Apr2021

Grant of second European Patent for Alkindi®

Exclusivity extended until 2034 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces the grant of a patent for Alkindi® (hydrocortisone granules in capsules for opening) by the European Patent Office. EP2978414, entitled “Composition Comprising Hydrocortisone”, is a patent disclosing and claiming the composition of Alkindi® for the treatment of paediatric patients with adrenal insufficiency (AI). The patent provides in-market European protection until 2034 in all designated states of the European Patent Convention. The equivalent patents from the same family are already granted in the UK, Japan, Australia, Israel, South Africa, South Korea, China, India, Russia and the US (for Alkindi ® Sprinkle). EP2978414 further expands the Company’s strong exclusivity position for Alkindi® in Europe, where Diurnal already has 10 years of data and market exclusivity until 2028 through a paediatric use marketing authorisation granted by the European Commission and previous granted patent EP2780003 claiming medical use of Alkindi® for the treatment of paediatric patients with AI. Alkindi® is approved and marketed as the first preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from AI and the related condition congenital adrenal hyperplasia. Martin Whitaker, CEO of Diurnal, commented: “With the continued commercialisation of Alkindi  ®  being a core focus for Diurnal, we are pleased to receive this patent grant by the European Patent Office. This patent, which builds on our strong global intellectual property position for the product, provides protection in Europe until 2034, supporting our continued commitment to provide Alkindi® to paediatric patients suffering from adrenal insufficiency.” For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Notes to Editors About Alkindi  ®  (hydrocortisone granules in capsules for opening) Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including paediatric AI and congenital adrenal hyperplasia (CAH). AI requires life-long treatment and Diurnal's novel approach to product development has the potential to significantly improve these young patients' lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is also approved in Israel and Australia. Alkindi® is known as Alkindi® Sprinkle in the US and was approved by the US Food and Drug Administration (FDA) on 29 September 2020. About Paediatric Adrenal Insufficiency Paediatric AI is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone). About Diurnal Group plc Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null Date of Preparation: April 2021 Code: CORP-GB-0116 View pdf document: null

15Apr2021

Request for maintenance of Orphan Designation for Efmody® withdrawn

European Efmody® launch, planned for Q3 2021, remains unchanged following earlier positive CHMP opinion supporting drug approval Granted European Efmody® patents provides protection until 2033 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has decided to withdraw its application for maintenance of Orphan Designation in Europe for Efmody® (hydrocortisone modified-release hard capsules – development name Chronocort®). This follows feedback from the Committee for Orphan Medicinal Products (COMP), an advisory committee to the European Medicines Agency (EMA). Diurnal has decided that continuing pursuit of an Orphan Designation for the drug would be likely to cause a significant delay in its European commercial launch. First commercial launch is currently anticipated to be in Q3 2021. As previously announced by the Company on 26 March 2021, the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the EMA, issued a positive opinion to the European Commission recommending Efmody ® as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH). The formal approval of marketing authorisation from the European Commission for Efmody®, which is not dependant on the maintenance of Orphan Designation, continues to be anticipated in June 2021, in accordance with the 67-day mandated timeline following the adoption of a positive opinion by the CHMP. In anticipation of this and commercial launch shortly thereafter, market access activities in the Company’s target European territories are underway. Orphan Designation provides for market exclusivity for 10 years from launch. However, the Company currently holds granted European patents for Efmody® for the treatment of patients with both CAH and adrenal insufficiency (AI) and believes these patents provide sufficient protection for Efmody® until at least 2033 in all designated states covered by the European Patent Convention. In addition, while Orphan Designation can be used to support premium pricing in certain territories, Diurnal does not believe that this is critical to the overall commercial potential of the product given the significant clinical need for new therapies in CAH. Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “Following the recent positive opinion from the CHMP we are focussed on the timely launch of Efmody® in Q3 2021. Orphan Designation for Efmody® in Europe is not critical to the commercial potential of the product in this market. There remains a strong clinical rationale for the drug’s use to address the significant need for new therapies to improve outcomes for adult patients with CAH. This was highlighted recently in the paper in the Journal of Clinical Endocrinology and Metabolism that detailed our pivotal clinical trial data and results from a long term extension study. Additionally, a robust, granted European patent estate provides market exclusivity for the drug until at least 2033.” For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Notes to Editors About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe, with over 400,000 in the rest of the world. About Efmody® (hydrocortisone modified release hard capsules) Efmody ®  is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody ®  is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody ®  has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The positive opinion from the CHMP is based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody ®  over an extended period, with a number of patients on this trial having been treated for over 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody ®  treatment. About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null Date of Preparation: April 2021 Code: CORP-GB-0115 View pdf document: null

26Mar2021

European Medicine Agency issues positive opinion for Diurnal’s second product in Europe

European Medicine Agency   issues positive opinion for Diurnal’s second product in Europe In preparation for commercial product launch in Europe, Chronocort ® to be branded as Efmody® Commercial launch anticipated in Q3 2021 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA) , has issued a positive opinion to the European Commission recommending Efmody® (hydrocortisone modified-release hard capsules – development name Chronocort®) as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH). The formal approval of marketing authorisation from the European Commission is anticipated in June 2021, in accordance with the 67-day timeline following the adoption of the positive opinion by the CHMP, together with a decision on grant of Orphan Drug Status. To facilitate timely commercial availability, Diurnal has already commenced market access activities in its target European territories, with the first commercial launch anticipated in Q3 2021. The Company intends to mirror its strategy for Alkindi® (hydrocortisone granules in capsules for opening) by commercialising the product itself in core European markets. Efmody® is a preparation of hydrocortisone that has been specifically designed for patients with CAH, an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are delighted that the CHMP endorses Efmody® as a treatment option for adult and adolescent patients suffering from congenital adrenal hyperplasia. We look forward to expanding our commercial portfolio with the planned launch of Efmody® across Europe alongside our first product Alkindi®, to provide life-long treatment for patients with congenital adrenal hyperplasia, enabling Diurnal to continue to drive towards becoming a world-leading specialty endocrinology business.” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker) +44 (0)20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting (Media and Investor Relations) +44 (0)20 3727 1000 Simon Conway Victoria Foster Mitchell Notes to Editors About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe, with over 400,000 in the rest of the world. About Efmody® ( hydrocortisone modified release hard capsules ) Efmody® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (administered last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first indication for Efmody® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents (children older than 12 years of age). Efmody® has been extensively studied in 239 human subjects including 138 CAH patients who have taken part in clinical trials in Europe and the US. The positive opinion from the CHMP is based on a Phase 3 study conducted in a total of 122 patients enrolled across 11 clinical sites, the largest ever interventional clinical trial completed in CAH. The Phase 3 data was supported by detailed analysis of data from an open-label safety extension study for patients completing treatment in the Phase 3 study, which is assessing the impact of treatment with Efmody ® over an extended period, with a number of patients on this trial having been treated for over 54 months. Patient retention rates in this study have been high and patients on this trial have, to date, shown sustained benefit from extended Efmody® treatment. About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null Date of Preparation: March 2021 Code: CORP-GB-0110 View pdf document: null

23Feb2021

Chronocort® distribution and marketing agreement with Consilient Health for the Nordics

Further builds Diurnal’s distribution platform ahead of anticipated European recommendation for approval of Chronocort® in Q1 2021 Extends relationship with Consilient Health following Benelux Union agreement for Alkindi® and Chronocort® Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has extended its distribution arrangements with Consilient Health to include the distribution and marketing of Chronocort® (modified-release hydrocortisone) in the Nordic region (consisting of Sweden, Norway, Denmark, Finland and Iceland). Under the terms of this agreement, Consilient Health, a pharmaceutical company with a track record in commercialising products for endocrinology, women's health and urology, will receive the exclusive rights to market and sell Chronocort® when approved, in the Nordics. The region represents a significant market opportunity for Diurnal, with around 2,300 adult patients suffering from congenital adrenal hyperplasia (CAH), providing an estimated total market opportunity for Chronocort® of approximately €11.5 million per annum. Chronocort® is a modified-release preparation of hydrocortisone that is under review by the European Medicines Agency (EMA).  Chronocort® is given in a twice-a-day regimen to treat diseases of cortisol deficiency. If regulatory review is favourable, a marketing authorisation opinion for Chronocort® approval in the European Economic Area is anticipated during Q1 2021. In September 2020, the Company announced that it had entered into an agreement with Consilient Health to cover the distribution and marketing of Alkindi® (hydrocortisone granules in capsules for opening) and Chronocort® in the Benelux Union (consisting of Belgium, the Netherlands, and Luxemburg). On approval, Diurnal will provide Chronocort® from its established European supply chain for sale by Consilient Health to the Nordics and Benelux Union. This agreement adds to the Company's ongoing strategy for commercialisation of its lead products by optimising market access outside of key European markets through entering marketing and distribution agreements with companies focused on niche and orphan conditions. Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We have been impressed with Consilient Health since signing our original contract with them in September 2020 and we look forward to building on this relationship to cover the commercialisation of Chronocort® in the Nordics. With a track record in commercialising products for endocrinology, Consilient Health are well placed to distribute Chronocort® in the Nordics and Benelux Union, if approved, where there is a significant unmet need for adults suffering from CAH. We continue to anticipate a positive regulatory opinion by the EMA during this quarter and today’s distribution agreement is in line with our strategy to optimise market access of our products outside of key European markets.”   Ahmed Al-Derzi, Chief Executive Officer of Consilient Health, commented: “We have enjoyed our partnership with Diurnal for the Benelux region that the two parties formed in 2020. Along with the rest of the Consilient Health team, I am delighted to be extending that partnership to include the Nordic region. Diseases of cortisol deficiency have significant unmet need and we feel privileged to work with Diurnal and bring new options to endocrinologists and patients in the Nordics.” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null  or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer  Richard Bungay, Chief Financial Officer  Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting +44 (0)20 3727 1000 Simon Conway  Victoria Foster Mitchell Notes to Editors About Chronocort® (modified-release hydrocortisone) Chronocort® is a preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first planned indication for Chronocort® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents. Chronocort® has been extensively studied in human subjects having completed four Phase I trials, a Phase II trial in 16 CAH patients in the US in 2014, and a Phase III trial in 122 CAH patients in Europe and the US. About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe, with over 400,000 in the rest of the world.  About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null   About Consilient Health Established in 2005 with headquarters in Ireland, Consilient Health is an independent, dynamic and rapidly growing pharmaceutical company with a rich heritage of commercialising products in complex markets in therapeutic areas such as women's health, urology and endocrinology. The company has a strategy of partnering with innovative companies to bring medicines to market that serve a clear unmet clinical need. For further information about Consilient Health, please visit  null       Date of Preparation: February 2021                    Code: CORP-EU-0017 View pdf document: null

23Feb2021

Interim Results for the Six Months Ended 31 December 2020

Alkindi® sales grow while new deals enable further geographic expansion; EMA approval of second drug, Chronocort®, expected in Q1 2021  Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its results for the six months ended 31 December 2020 (the “Period”) and follows publication of a trading update on 14 January 2021.  Operational highlights   null null null null Financial highlights null null null null Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented: “Diurnal has continued to make excellent progress during the Period in making Alkindi® available to patients around the world. Notably, Alkindi® Sprinkle received regulatory approval in the US and was subsequently launched there by our partner, Eton. We are pleased with the growth in Alkindi® revenues, despite previously highlighted pandemic-related restrictions in Europe, and look forward to this growth accelerating, especially when pandemic restrictions begin to lift.”  “Looking forward, our commercial focus is now on preparation for the anticipated approval and initial launches of Chronocort® in congenital adrenal hyperplasia during 2021, to significantly expand our European cortisol deficiency franchise, towards profitability. Separately, we continue to make good progress in development activities with Chronocort® in the US and Japan, as well as potential indication expansion into adrenal insufficiency. In addition, we are preparing for the next phase of development of DITEST™ in the US as an innovative, testosterone-based, potential treatment for hypogonadism and this is a major commercial opportunity within our pipeline of products.”   In the Interim Results:  null null This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).  For further information, please visit  null  or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer  Richard Bungay, Chief Financial Officer  Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting +44 (0)20 3727 1000 Simon Conway  Victoria Foster Mitchell Consolidated income statement for the six months ended 31 December 2020 Notes to Editors About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null Forward looking statements   Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the Company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward-looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods. View full document:  null

02Feb2021

Chronocort® Phase 3 and Safety Extension Study results published in JCEM

Peer-reviewed data from largest ever completed interventional clinical trial in CAH Authors conclude that Chronocort® provides a well-tolerated and practical twice-daily treatment regimen for CAH Data also forms part of EMA and MHRA submissions with anticipated positive regulatory opinion in Q1 2021 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the endocrinologist-focused  Journal of Clinical Endocrinology and Metabolism  (“JCEM”) has today published the peer-reviewed results of the Company’s Phase 3 clinical trial and extension study for Chronocort® (hydrocortisone modified-release hard capsules) in patients with the rare condition congenital adrenal hyperplasia (CAH). The Company's Phase 3 study was conducted in a total of 122 patients enrolled across 11 clinical sites, the largest ever interventional clinical trial completed in CAH patients. Data are also presented from an open-label safety extension study for patients completing treatment in the Phase 3 study. These data assessed the impact of treatment with Chronocort® over a further period of 18 months. A significant proportion of patients eligible to enter the follow-on study did so, and patient retention rates in this study remain high. As previously announced, the Phase 3 study results published by the JCEM found that although the standard-deviation-score-focused primary endpoint of the study was missed, Chronocort® improved morning and early afternoon biochemical control for adults with CAH over standard glucocorticoid therapy. In the safety extension study, biochemical control was sustained for 18 months on median hydrocortisone doses in the range recommended for cortisol replacement therapy and lower than glucocorticoid doses normally used in the treatment of CAH. The manuscript concludes that Chronocort® provides a well-tolerated and practical twice-daily treatment regimen for CAH in adults, due to a deficiency of 21-hydroxylase. The JCEM advanced article, entitled “ Modified-release Hydrocortisone in Congenital Adrenal Hyperplasia ” can be accessed here: null Chronocort® is a modified-release preparation of hydrocortisone that is under review by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), with the submissions based on the Phase 3 clinical trial and safety extension study data. If regulatory review is successful, marketing authorisation opinions for Chronocort® approval in the European Economic Area (including Northern Ireland) and Great Britain are anticipated during Q1 2021. Data from the JCEM manuscript, the Chronocort® Phase 3 clinical trial and extension study will be included in the Company’s analyst presentation, on Tuesday 23 February 2021 for the financial results for the six months ended 31 December 2020, which will be available on the Company’s website shortly thereafter. Professor Richard Ross, a founding Director of Diurnal and Chief Scientific Officer, commented: “The team at Diurnal and I are delighted to have our data from the Chronocort® Phase 3 clinical trial and safety extension study published in the prestigious Journal of Clinical Endocrinology and Metabolism. These results confirm the effectiveness of Chronocort®, which provides a much needed, well-tolerated and practical twice-daily treatment regimen for adults with CAH due to a deficiency of 21-hydroxylase.” Martin Whitaker, Chief Executive Officer of Diurnal, commented: “Today’s peer-reviewed publication in the JCEM is a significant milestone and discloses the full data set behind our European pivotal clinical study for Chronocort® as a potential treatment for CAH. This data has also formed part of our submissions to the EMA and MHRA, where we anticipate positive regulatory opinion during this quarter. If approved, Chronocort® could be a valuable treatment option for CAH patients across Europe, a rare condition that we estimate affects a total of approximately 41,000 people.” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null  or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer  Richard Bungay, Chief Financial Officer  Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting +44 (0)20 3727 1000 Simon Conway  Victoria Foster Mitchell Notes to Editors About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic glucocorticoid (steroids including hydrocortisone, dexamethasone, prednisolone and prednisone in the US) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe, with over 400,000 in the rest of the world. About Chronocort® Chronocort® is a modified-release preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first planned indication for Chronocort® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents. Chronocort® has been extensively studied in human subjects having completed four Phase I trials, a Phase II trial in 16 CAH patients in the US in 2014, and a Phase III trial in 122 CAH patients in Europe and the US. About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null Date of Preparation: February 2021                    Code: CORP-GB-0100 View pdf document:  null

27Jan2021

China licencing agreement with Citrine Medicine for Alkindi®

Diurnal partners with China-based rare disease therapeutics company Total up-front payment and future milestones of up to $13.25 million, with double-digit royalties on sales Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has entered into an exclusive licence agreement for its product, Alkindi® (hydrocortisone granules in capsules for opening), with the specialty pharmaceutical company, Citrine Medicine, Inc. (“Citrine”) covering China, Hong Kong, Taiwan and Macau. Under the terms of the licence agreement, Diurnal will receive a non-refundable upfront payment of $0.5 million and will receive $12.75m in additional cash payments upon achievement of certain regulatory milestones and sales milestones based on annual sales thresholds. Diurnal will receive tiered royalties on sales ranging from low to mid double-digits. Citrine is a therapeutics platform company focused on the Greater China market that was co-founded by Vivo Capital, F-Prime Capital and Eight Roads Ventures. Citrine is focused on creating a therapeutic platform to deliver rare disease drugs to the Chinese market and to develop the first ever rare disease ecosystem in the country. Citrine will be responsible for obtaining registration for Alkindi® as a treatment for paediatric patients in China and for all commercialisation activities, including pricing and reimbursement. Citrine will initially utilise product from Diurnal’s European supply chain, with an option to establish its own supply chain in China in the future. It is estimated that congenital adrenal hyperplasia (CAH) occurs in 1 in 6,084 births in China1. CAH is a group of genetic conditions that limit hormone production in the adrenal glands and was identified a rare disease by the Chinese health authorities in May 2018. Martin Whitaker, CEO of Diurnal, commented: “With the increased focus from the Chinese health authorities on rare diseases in the past few years, we are delighted to have identified Citrine as a partner for Alkindi® in China. We have been impressed by Citrine’s vision for the creation of a rare disease platform in China and the local development, regulatory and commercialisation expertise they are able to bring to the programme. We believe they are well positioned to maximise the value of Alkindi® in this key market. If approved, Alkindi® will provide a major breakthrough in China as the only licensed treatment specifically designed for use in children with CAH, where there is a significant unmet patient need.” Melissa Bradford-Klug, Chief Business Officer of Citrine, commented: “There are currently no drugs approved in China to treat pediatric patients with CAH, a disease of high unmet need. We are very excited about this partnership as it opens a path for us to bring an important new medicine to patients who need it and demonstrates the strong potential for cross-border collaborations to benefit patients with rare diseases worldwide. We look forward to continuing to work with biopharma companies across the US and Europe to bring additional rare disease medicines to China.” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). 1 Zhong, K. et al. (2016) ‘The status of neonatal screening in China, 2013’, Journal of Medical Screening, 23(2), pp. 59–61. doi: 10.1177/0969141315597715. For further information, please visit  null  or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer  Richard Bungay, Chief Financial Officer  Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting +44 (0)20 3727 1000 Simon Conway  Victoria Foster Mitchell Notes to Editors About Alkindi® (hydrocortisone granules in capsules for opening) Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including paediatric AI and CAH. AI requires life-long treatment and Diurnal's novel approach to product development has the potential to significantly improve these young patients' lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is approved and known as Alkindi® Sprinkle in the US where it is licensed and marketed by Eton Pharmaceuticals. Alkindi® is also approved in Israel and Australia. About Congenital Adrenal Hyperplasia in Children Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. In children, the cortisol deficiency and over-production of male sex hormones can lead to increased mortality, issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis if they do not have adequate cortisol replacement. About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null About Citrine Medicine Citrine Medicine is dedicated to improving the lives of patients with rare and intractable diseases by making diagnosis and essential treatments available and accessible to those who need them in China. Their mission is to build the first rare disease ecosystem in China and in doing so, enable people with rare diseases to live more normal lives. In addition to developing and marketing rare disease drugs, Citrine aims to establish a patient-centric platform which educates people on rare diseases, trains doctors on diagnosis and treatment, and helps doctors develop a full disease management protocol. Citrine is headquartered in Shanghai and has offices in Beijing, China and Cambridge, Mass, US.  For further information about Citrine Medicine, please visit  null  Date of Preparation: January 2021            Code: CORP-GB-0095 View pdf document:  null

14Jan2021

BUSINESS AND TRADING UPDATE

Continued growth in Alkindi sales despite impact of Covid-19 on hospital visits and new launches Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today provides a business and unaudited trading update for the six months ended 31 December 2020. Financial highlights Revenue null null Cash null null null null Operational highlights  null null null null Martin Whitaker, Chief Executive Officer of Diurnal, commented: “Diurnal is pleased that Alkindi® revenues have continued to grow despite the significant challenges in access to hospitals due to Covid-19 pandemic restrictions, impacting both patients and our commercial team. The trajectory of Alkindi® growth in the second half of the financial year, and hence our full year product sales, will be dependent on when the pandemic restrictions are eased; however, we expect as a minimum to maintain reasonable growth in our core commercial markets and believe, once the pandemic has eased, growth will significantly accelerate. We are also pleased with the continued geographic expansion for Alkindi®, highlighting the value for patients across the globe, and look forward to announcing further partnerships in due course. “We are now preparing for the anticipated approval of Chronocort® in the first quarter of 2021 and the subsequent commercial launch and roll-out, as we progress our European cortisol deficiency franchise towards profitability.” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null null null  or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer  Richard Bungay, Chief Financial Officer Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting +44 (0)20 3727 1000 Simon Conway  Victoria Foster Mitchell Notes to Editors About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null null Date of Preparation: January 2021     Code: CORP-GB-0093 null null View pdf document:  null

14Jan2021

LICENCING AGREEMENT WITH ETON PHARMACEUTICALS FOR ALKINDI® EXTENDED TO CANADA

Expands Alkindi® availability outside of key European and US commercial markets Grant of second Alkindi® patent in Canada Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has extended its exclusive licence arrangement for Alkindi® (hydrocortisone granules in capsules for opening) with Eton Pharmaceuticals, Inc. (“Eton”) to include Canada. In addition, the Company has been granted a key Canadian patent (No: CA2854717) claiming method of treatment for Alkindi®. In March 2020, Diurnal entered into an exclusive licence agreement for Alkindi® Sprinkle (as Alkindi® is known in the US) in the US with Eton, a specialty pharmaceutical company focused on developing and commercialising innovative treatments for rare paediatric diseases. Following approval by the US Food and Drug Administration, Eton announced in November 2020 that Alkindi® Sprinkle is available for sale and distribution in the US. Under the terms of the new licence agreement, Eton will be responsible for obtaining registration for Alkindi® in Canada for the treatment of paediatric patients suffering from adrenal insufficiency and for all commercialisation activities, including pricing and reimbursement. Eton will initially utilise product from Diurnal’s European supply chain, with an option to establish its own supply chain in the future. Diurnal will receive a royalty on future sales in Canada. CA2854717, entitled “Treatment of Adrenal Insufficiency in Children”, is a patent disclosing and claiming method of treatment for Alkindi® and, together with granted Canadian patent (No: CA2909060 claiming the composition of Alkindi®), provides patent exclusivity in the territory until 2034. The corresponding US patents have already been granted. Martin Whitaker, CEO of Diurnal, commented: “Following the approval of Alkindi® Sprinkle in the US there has been significant interest in the product from physicians and patient groups in Canada. We continue to be impressed by Eton’s enthusiasm and vision for Alkindi® Sprinkle and are pleased to extend our collaboration to potentially bring the product to paediatric patients in Canada suffering with adrenal insufficiency, where there is a significant unmet patient need. This latest deal further broadens the strong exclusivity position and future availability of Alkindi® outside of our core markets in line with our global strategy.” Sean Brynjelsen, CEO of Eton, commented: “We are excited to expand our partnership with Diurnal to include the Canadian market. We look forward to making the product available to Canadian patients as quickly as possible and building off of the early success we have experienced marketing Alkindi® Sprinkle in the United States.”. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null  or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer  Richard Bungay, Chief Financial Officer  Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting +44 (0)20 3727 1000 Simon Conway  Victoria Foster Mitchell Notes to Editors About Alkindi® (hydrocortisone granules in capsules for opening) Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients suffering from diseases due to cortisol deficiency including paediatric AI and congenital adrenal hyperplasia (CAH). AI requires life-long treatment and Diurnal's novel approach to product development has the potential to significantly improve these young patients' lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is known as Alkindi® Sprinkle in the US and was approved by the US Food and Drug Administration (FDA) on 29 September 2020. Alkindi® is also approved in Israel and Australia. About Paediatric Adrenal Insufficiency Paediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone). About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit   null   Date of Preparation: January 2021                     Code: CORP-GB-0094 View pdf document:  null

13Jan2021

DIURNAL SIGNS AGREEMENT WITH ER-KIM FOR THE DISTRIBUTION OF ALKINDI® AND CHRONOCORT® IN TURKEY

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces a distribution agreement with Er-Kim, a leading partner for global biotech and pharma companies seeking to commercialise their products in Turkey. The agreement covers the distribution of the Company’s products Alkindi® (hydrocortisone granules in capsules for opening) and Chronocort® (modified-release hydrocortisone). The products will be available for the patients who qualify in Turkey through applicable Early Access programmes for patients with diseases of cortisol deficiency who have no other treatment option. Under the terms of the agreement, Er-Kim will receive the exclusive rights to distribute, and when approved, market Alkindi® and Chronocort® in Turkey. There are over 8,800 patients estimated to be currently receiving treatment for paediatric Adrenal Insufficiency (AI) and the genetic condition Congenital Adrenal Hyperplasia (CAH). Alkindi® is already approved in Europe, Israel and Australia and is the first preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from AI, including the related condition CAH. Alkindi® is known as Alkindi® Sprinkle in the US and was approved by the US Food and Drug Administration in September 2020. Chronocort® is a modified-release preparation of hydrocortisone that is under review by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).  Chronocort® is given in a twice-a-day regimen to treat diseases of cortisol deficiency. If regulatory review is successful, a marketing authorisation opinion for Chronocort® approval in the European Economic Area (and Great Britain and Northern Ireland) is anticipated during Q1 2021. Diurnal will provide Alkindi® (and subsequently Chronocort® on approval) from its established European supply chain for sale by Er-Kim. This agreement adds to the Company's ongoing strategy for commercialisation of its lead products by optimising market access outside of key European markets through entering marketing and distribution agreements with companies focused on niche and orphan conditions. Martin Whitaker, CEO of Diurnal, commented: “We are pleased to sign this agreement with Er-Kim, who have the local expertise and proven track record in Turkey needed to successfully support requests for Alkindi® and Chronocort® under an Early Access programme. This distribution agreement may help support patient needs in diseases of cortisol deficiency. Working with Er-Kim broadens the future availability of both Alkindi® and Chronocort® outside of our core markets in line with our global strategy. We have been impressed with Er-Kim and believe that our strategy is aligned with theirs as a valued distribution partner.” Cem Zorlular, Chairman and CEO of Er-Kim, commented: “We are excited to be working with Diurnal to bring Alkindi® and Chronocort® to Turkey where there is a significant unmet medical need for patients with adrenal insufficiency and congenital adrenal hyperplasia. We are both aligned to an objective of making these much needed, high quality medicines available to patients who currently have no other satisfactory option for treatment.” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null null null  or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer  Richard Bungay, Chief Financial Officer  Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting +44 (0)20 3727 1000 Simon Conway  Victoria Foster Mitchell Notes to Editors About Alkindi® (hydrocortisone granules in capsules for opening) Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenal insufficiency (AI). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from diseases due to cortisol deficiency including paediatric AI and congenital adrenal hyperplasia (CAH). AI requires life-long treatment and Diurnal's novel approach to product development has the potential to significantly improve these young patients' lives. The European Commission has granted a paediatric use marketing authorisation (PUMA) for Alkindi® as replacement therapy of AI in infants, children and adolescents (from birth to <18 years old) in Europe. Alkindi® is also approved in Israel and Australia. Alkindi® is approved and known as Alkindi® Sprinkle in the US where it is licensed and marketed by Eton Pharmaceuticals.     About Paediatric Adrenal Insufficiency Paediatric AI, including the genetic condition CAH is a condition characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. The primary symptoms of AI are chronic fatigue and patients are at risk of adrenal crisis and death if they do not have adequate cortisol replacement. AI is either primary or secondary, with primary AI resulting from diseases intrinsic to the adrenal gland and secondary AI resulting from pituitary diseases where there is a failure of stimulation of the adrenal by the pituitary of the signalling hormone ACTH (adrenocorticotropic hormone). About Chronocort® Chronocort® is a modified-release preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first planned indication for Chronocort® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents. Chronocort® has been extensively studied in human subjects having completed four Phase I trials, a Phase II trial in 16 CAH patients in the US in 2014, and a Phase III trial in 122 CAH patients in Europe and the US. About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic steroids (hydrocortisone, dexamethasone and prednisolone) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe, with over 400,000 in the rest of the world. About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null null null About Er-Kim Er-Kim is a leading commercial partner for global biotech and pharma companies seeking to commercialise their products in Turkey, Europe and Middle East. In its 40-year of presence, Er-Kim has commercialised over 150 original therapies from more than 50 leading global pharmaceutical companies. Additionally, Er-Kim operates in drug discovery for unmet needs in rare blood diseases and R&D providing cost-effective manufacturing of advanced medicinal products easing the economic burden of the healthcare system. For further information about Er-Kim, please visit  null     Date of Preparation: January 2021                     Code: CORP-GB-0092 View pdf document:  null

12Jan2021

CHRONOCORT® MARKETING AUTHORISATION APPLICATION SUBMITTED TO THE UK MHRA

Independent UK (MHRA) application to run in parallel with ongoing European (EMA) application, following end of Brexit Transition period Both EMA and MHRA marketing authorisations anticipated in Q1 2021 to address European market Significant opportunity to address unmet patient need in a market estimated at $250 million Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that an ‘in flight’ Market Authorisation Application (MAA) has been submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Chronocort® (modified-release hydrocortisone) as a treatment for adult and adolescent patients with the rare condition congenital adrenal hyperplasia (CAH) in Great Britain (England, Wales and Scotland). The MAA submission follows MHRA guidance following the end of the Brexit Transition Period and follows submission of an MAA to the European Medicines Agency (EMA) in December 2019, which was subsequently validated by the EMA in April 2020 and has continued along its planned review path with a marketing authorisation opinion for Chronocort® approval in the European Economic Area anticipated in Q1 2021. The submission for the MHRA is based on the same application submitted to the EMA in December 2019, including detailed analysis of data from the Company’s Phase 3 study, the largest ever interventional clinical trial in CAH, an open-label safety extension study of Chronocort® and written formal Scientific Advice received in April 2019 confirming the clinical and regulatory pathway for Chronocort® as a treatment for patients with CAH. In parallel with the MHRA submission, Diurnal will seek confirmation of British Orphan Drug Status for Chronocort® in CAH, which requires the Company to demonstrate significant clinical benefit for the product compared to existing therapies. Should Chronocort® be approved, it will provide the potential for life-long treatment across Europe, with patients commencing treatment with Alkindi® (hydrocortisone granules in capsules for opening), the Company’s approved paediatric product, transitioning to Chronocort® in adolescence and continuing with Chronocort® treatment into later life. Martin Whitaker, CEO of Diurnal, commented: “We are pleased to announce one of the first submissions of a Marketing Authorisation Application to the MHRA via the “in flight” process. Chronocort® remains on track to be approved by the EMA during Q1 2021, with the MHRA approval also now expected during this period. We look forward to the potential launch of our second product in Great Britain and European Economic Area as we continue to build our commercial portfolio and drive towards becoming a world-leading specialty endocrinology business. There is a significant need for new therapies to improve outcomes for adult patients with CAH, which still results in increased morbidity and mortality worldwide. We believe that Chronocort®, together with our paediatric product Alkindi®, has the potential to provide new treatment options for CAH patients throughout their lives.” CAH is an orphan condition caused by a block in cortisol production, an essential adrenal steroid hormone required for healthy life. A lack of cortisol in turn causes the over-production of male steroid hormones (androgens). Cortisol deficiency and over-production of androgens can lead to increased mortality, infertility and issues during sexual development, including ambiguous genitalia, precocious puberty and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. The condition is estimated to affect a total of approximately 41,000 patients in Europe, with over 400,000 in the rest of the world. For further information, please visit  null null null  or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer  Richard Bungay, Chief Financial Officer  Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting +44 (0)20 3727 1000 Simon Conway  Victoria Foster Mitchell Notes to Editors About Chronocort® Chronocort® is a modified-release preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first planned indication for Chronocort® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents. Chronocort® has been extensively studied in human subjects having completed four Phase I trials, a Phase II trial in 16 CAH patients in the US in 2014, and a Phase III trial in 122 CAH patients in Europe and the US. About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic steroids (hydrocortisone, dexamethasone and prednisolone) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe, with over 400,000 in the rest of the world. About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing hormone therapeutics for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information about Diurnal, please visit  null null null Date of Preparation: January 2021      Code: CORP-GB-0091 View pdf document:  null

11Jan2021

GRANT OF EUROPEAN PATENT FOR CHRONOCORT®

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces the grant of a key patent for Chronocort® (modified release hydrocortisone) by the European Patent Office. EP2814469, entitled “Hydrocortisone controlled-release formulation”, is a patent disclosing and claiming the composition of matter and medical use of Chronocort® for the treatment of patients with the rare diseases congenital adrenal hyperplasia (CAH) and adrenal insufficiency (AI). The patent provides in-market European protection until 2033 in all designated states of the European Patent Convention. The equivalent patents from the same family are already granted in the UK, Canada, Mexico, New Zealand, Japan, Australia, Israel, South Africa, South Korea and in the US. The Marketing Authorisation Application (MAA) for Chronocort® as a treatment for adolescents and adults with CAH is under review by the European Medicines Agency (EMA) following submission of the MAA dossier in December 2019. The MAA was subsequently validated and accepted for review by the EMA in April 2020 and the outcome of the EMA review is anticipated during Q1 2021. Martin Whitaker, CEO of Diurnal, commented:  “With the anticipated approval of Chronocort ®  in Europe later this quarter, we are pleased to receive this patent grant by the European Patent Office. This patent, which builds on our strong global intellectual property position for the product, provides protection in Europe until 2033, supporting our continued commitment to develop Chronocort® for the treatment of patients suffering from congenital adrenal hyperplasia and subsequently adrenal insufficiency.” This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). For further information, please visit  null  or contact: Diurnal Group plc +44 (0)20 3727 1000 Martin Whitaker, Chief Executive Officer  Richard Bungay, Chief Financial Officer  Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker) +44 (0) 20 7886 2500 Corporate Finance: Freddy Crossley, Emma Earl Corporate Broking: Rupert Dearden FTI Consulting +44 (0)20 3727 1000 Simon Conway  Victoria Foster Mitchell Notes to Editors About Chronocort® Chronocort® is a modified release preparation of hydrocortisone that has been specifically designed to mimic the circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen (last thing at night before sleep and first thing in the morning on waking) to control androgen excess and chronic fatigue in patients with diseases of cortisol deficiency. The first planned indication for Chronocort® is Congenital Adrenal Hyperplasia (CAH) in adults and adolescents. Chronocort® has been extensively studied in human subjects having completed four Phase I trials, a Phase II trial in 16 CAH patients in the US in 2014, and a Phase III trial in 122 CAH patients in Europe and the US. About Congenital Adrenal Hyperplasia Congenital adrenal hyperplasia (CAH) is an orphan condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase. This enzyme is required to produce the adrenal steroid hormone, cortisol. The block in the cortisol production pathway causes the over-production of male steroid hormones (androgens), which are precursors to cortisol. The condition is congenital (inherited at birth) and affects both sexes. The cortisol deficiency and over-production of male sex hormones can lead to increased mortality, infertility and issues during sexual development including ambiguous genitalia, premature (precocious) sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. Current therapy for CAH uses a variety of generic steroids (hydrocortisone, dexamethasone and prednisolone) with no standard treatment regimen. Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 41,000 patients in Europe, with over 400,000 in the rest of the world. About Diurnal Group plc Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency and hypogonadism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena. For further information about Diurnal, please visit  null   Date of Preparation: January 2021      Code: CORP-GB-0089 View pdf document:  null

Diurnal Group plc (Company Number: 09846650) is registered in England & Wales. Registered office: Cardiff Medicentre, Heath Park, Cardiff CF14 4UJ, UK.