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.

Share price

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

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

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