John Goddard, Non-executive Director, sold 38,461 Ordinary Shares at a price of 33 pence per Ordinary Share and purchased 38,361 Ordinary Shares at a price of 33.08 pence per Ordinary Share. Founded in 2004, Diurnal is a UK- headquartered, European-based specialty pharma company developing pharmaceutical products for the global market for the life-long...
Diurnal 38.5p £47m (DNL.L) The specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that a presentation, entitled 'A Phase 3 Study of a Modified-Release Hydrocortisone in the Treatment of Congenital Adrenal Hyperplasia,' will be presented by Deborah P. Merke, MD, MS, from NIH Clinical Center and NICHD, Bethesda, MD, USA, at ENDO Online 2020. The presentation will focus on data from Diurnal's Phase 3 clinical trial of Chronocort® (modified release hydrocortisone) for the treatment of congenital adrenal hyperplasia (CAH) in adults, the largest interventional study conducted to date in this patient population. The Phase 3 data forms the basis for Diurnal's Marketing Authorisation Application (MAA) for Chronocort® in Europe. The MAA is currently under review following submission to the European Medicines Agency (EMA) in December 2019 and validation in April 2020. Diurnal is targeting recommendation for approval of Chronocort® by the EMA in Q1 2021. The presentation is part of the on-demand programme during the online conference, which will be available to view for free from 11:00 EDT on Monday 8 June 2020 until Monday 22 June 2020. To register for ENDO Online 2020 to view the presentation, please visit www.endocrine.org/meetings-andevents/endo-online-2020 #DNL
Diurnal Group Plc (DNL.L) Announced that a presentation, entitled 'A Phase 3 Study of a Modified-Release Hydrocortisone in the Treatment of Congenital Adrenal Hyperplasia,' will be presented by Deborah P. Merke, MD, MS, from NIH Clinical Center and NICHD, Bethesda, MD, USA, at ENDO Online 2020. The presentation will focus on data from Diurnal's Phase 3 clinical trial of Chronocort (modified release hydrocortisone) for the treatment of congenital adrenal hyperplasia (CAH) in adults, the largest interventional study conducted to date in this patient population. #DNL
RNS Number: 3237 P Diurnal Group PLC 09 June 2020 09 June 2020. Diurnal Group plc, the specialty pharmaceutical company targeting patient needs in chronic endocrine diseases, announces that a presentation, entitled' A Phase 3 Study of a Modified-Release Hydrocortisone in the Treatment of Congenital Adrenal Hyperplasia,' will be presented by Deborah P. Merke, MD,...
RNS Number: 2704 O Diurnal Group PLC 29 May 2020 29 May 2020. Founded in 2004, Diurnal is a UK- based specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia and adrenal insufficiency. RNS is approved by the Financial Conduct...
RNS Number: 4694 L Diurnal Group PLC 30 April 2020. A second and final Price Monitoring Extension has been activated in this security. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom.
RNS Number: 4683 L Diurnal Group PLC 30 April 2020. The auction call period has been extended in this security by 5 minutes. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom.
RNS Number: 3368 K Diurnal Group PLC 21 April 2020 21 April 2020. Director Dealings and Issue of Equity. Diurnal Group plc, the specialty pharmaceutical company targeting patient needs in chronic endocrine diseases, announces the following share dealings by Directors:.
Richard Ross, Chief Scientific Officer sold 125,000 Ordinary Shares at a price of 30 pence per Ordinary Share; his and his wife's respective ISAs purchased 125,000 Ordinary Shares in aggregate at a price of 30.02 pence per Ordinary Share. Founded in 2004, Diurnal is a UK- headquartered, European-based specialty pharma company developing pharmaceutical...
RNS Number: 7925 J Diurnal Group PLC 15 April 2020. A second and final Price Monitoring Extension has been activated in this security. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom.
RNS Number: 7896 J Diurnal Group PLC 15 April 2020. The auction call period has been extended in this security by 5 minutes. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom.
Diurnal (DNL.L): Operational Update Market capitalisation: £33.5m; Share price: 28p Diurnal, the developer of therapies for rare hormonal diseases, provided a business update. Measures are in place for the continuation of the Group’s safety extension study testing Chronocort®. No subjects have been required to leave the study to date as a result of COVID-19 restrictions. Alkindi® revenues in Europe are in-line with Board expectations. There have been no material delays regarding the regulatory processes for Chronocort® in Europe and Alkindi® in the US. Management believe Diurnal has sufficient cash to reach profitability having completed a £11.2m placing and received an upfront payment of $3.5m as part of a US licencing agreement with Eton Pharmaceuticals (ETON.NQ) regarding Alkindi®. Diurnal continue to progress the business despite the Covid-19 pandemic. The FDA is reviewing the Group’s New Drug Application (NDA) for Alkindi® Sprinkle with an approval decision expected in Q420. Alkindi® has already been approved in Europe and posted H1-20 revenues of £1.1m (H1-19: £0.2m). A recent placing and an upfront payment from Eton Pharma has provided the Group with capital to commercialise its second asset, Chronocort® for the treatment of patients with congenital adrenal hyperplasia. In December, the Group submitted a Market Authorisation Application (MAA) to the EMA, the European regulator, for Chronocort® with a decision expected in Q121. *One of the authoring analysts has an interest in Diurnal shares #DNL
Diurnal 32.5p £39.5m #DNL Business update in relation to clinical, regulatory and commercial operations in the context of the current global coronavirus (COVID-19) outbreak. · Clinical study participation - Participating centres in Diurnal's currently ongoing clinical trial, the DIUR-006 Chronocort® (modified release hydrocortisone) European safety extension study, have arranged for remote monitoring of subjects and plans are in place to ensure that patients have access to the drug. No subjects have been required to leave the DIUR-006 study to date as a result of restrictions imposed by virtue of the COVID-19 outbreak. Drug supply - To mitigate the impact of potential closure of state borders and protect patients from any consequential reduction in supply of Alkindi®, the Company has ensured that enough drug stock is available to meet foreseeable demand across all key European territories. Alkindi® revenues in Europe continue to track in line with the Board's expectations. The Company has not experienced any material delays to the regulatory processes for Chronocort® in Europe and Alkindi® Sprinkle in the US. Diurnal will continue to work with the European Medicines Agency (EMA) and US Food & Drug Administration (FDA), respectively, during the review processes and remains confident in the regulatory pathway timelines previously provided. The Board believe that the Company has enough cash to take it through to profitability based upon current plans and assumptions, including expectations regarding the timing of product approvals and sales projections.
Diurnal Group Plc #DNL announced, in its operational update, that the company's small number of office-based staff are now working remotely, and contingency plans have been established to support business continuity. Participating centres in Diurnal's currently ongoing clinical trial, the DIUR-006 Chronocort® (modified release hydrocortisone) European safety extension study, have arranged for remote monitoring of subjects and plans are in place to ensure that patients have access to the drug. To mitigate the impact of potential closure of state borders and protect patients from any consequential reduction in supply of Alkindi®, the company has ensured that enough drug stock is available to meet foreseeable demand across all key European territories. To date, the company has not experienced any material delays to the regulatory processes for Chronocort® in Europe and Alkindi® Sprinkle in the US. Following the announcement of its deal with Eton Pharmaceuticals for the exclusive licensing rights for Alkindi® Sprinkle in the US on 27 March 2020, the company has now received the initial non-refundable upfront payment of $3.5 million.
RNS Number: 6414 J Diurnal Group PLC 15 April 2020 15 April 2020. Arrangements in place to ensure constant drug supply to patients across Europe. Steps taken to minimise impact of COVID-19 on business operations.
Martin Whitaker purchased a total of 19,146 Ordinary Shares at 29.3 pence per share, to be held in pension schemes for the beneficial interest of his dependent children.. Founded in 2004, Diurnal is a UK- headquartered, European-based specialty pharma company developing pharmaceutical products for the global market for the life-long treatment of chronic...
Diurnal Group 30.5p £37.1m (DNL.L) Diurnal, announces that the Marketing Authorisation Application (MAA) for Chronocort® (modifie d release hydrocortisone) as a treatment for the rare condition congenital adrenal hyperplasia (CAH) in Europe has passed validation with the European Medicines Agency.The EMA validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. CAH is an orphan genetic 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 41k adult patients in Europe, with over 400k in the rest of the world. #DNL
Diurnal #DNL : Marketing Authorisation Application validation Share price: 30.5p; Market Capitalisation: £37.1m Diurnal, the developer of therapies for rare hormonal diseases, provided an update regarding its Marketing Authorisation Application (MAA) for Chronocort® which has been submitted to the EMA, the European regulator. The Chronocort® MAA has been validated by the EMA which are now beginning the formal review process. Chronocort® is a potential candidate for the treatment of patients with congenital adrenal hyperplasia (CAH), a rare condition thought to affect 41,000 adult patients in Europe. The validation of the MAA is a positive step toward achieving regulatory approval for Chronocort®, for which an approval decision is expected in Q121 with a recent placing providing sufficient capital to commercialise Chronocort®. If approved, this would be the second product to be approved by the EMA, the first being Alkindi®, a hormone replacement therapy for adrenal insufficiency, an orphan disease. In H120, Alkindi posted revenues of £1.1m (H119: £0.2m). *One of the authoring analysts has an interest in Diurnal shares
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