Welcome to Diurnal

Dedicated to bringing products to the global endocrine market

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.

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Mission Statement

To address the major unmet clinical and patient needs in endocrinology by creating products for the lifelong treatment of chronic conditions.

Latest News

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

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