This company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsDiurnal Group (4UU) 주식 개요Diurnal Group plc operates as a specialty pharma company worldwide. 자세히 보기4UU 펀더멘털 분석스노우플레이크 점수가치 평가2/6미래 성장2/6과거 실적0/6재무 건전성5/6배당0/6강점수익은 연간 62.15% 증가할 것으로 예상됩니다.위험 분석지난 3개월 동안 주가 변동성이 German 시장과 비교했을 때 매우 높았습니다.의미 있는 시가총액이 없습니다(€48M)cash runway 경력이 1년 미만입니다.지난 1년 동안 주주가 희석되었습니다.모든 위험 점검 보기4UU Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW484,833 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINROAG484,833 investors already sharing narrativesYour Fair Value€Current Price€0.28해당 없음내재 할인율Est. Revenue$PastFuture-26m53m2016201920222025202620282031Revenue UK£52.5mEarnings UK£9.4mAdvancedSet Fair ValueView all narrativesDiurnal Group plc 경쟁사MedigeneSymbol: XTRA:MDG1Market cap: €1.8mHeidelberg PharmaSymbol: XTRA:HPHAMarket cap: €119.3m2investSymbol: XTRA:2INVMarket cap: €62.9mco.donSymbol: XTRA:CNWMarket cap: €6.5m가격 이력 및 성과Diurnal Group 주가의 최고가, 최저가 및 변동 요약과거 주가현재 주가€0.2852주 최고가€0.7952주 최저가€0.08베타0.341개월 변동2.92%3개월 변동250.31%1년 변동-59.13%3년 변동n/a5년 변동n/aIPO 이후 변동-16.32%최근 뉴스 및 업데이트공고 • Nov 03Diurnal Group Announces Delisting and Cancellation of Trading of SharesFurther to the announcement made by the boards of Neurocrine and Diurnal Group plc on November 1, 2022 that the Scheme has become Effective in accordance with its terms, Diurnal confirmed that the admission to trading of Diurnal Shares on the AIM Market of the London Stock Exchange has been cancelled with effect from 7:00 a.m. on November 2, 2022.공고 • Nov 02Diurnal Group plc Shares Suspend from AIMTrading in Diurnal Group plc shares on AIM was suspended with effect from 7.30 a.m. today, November 1, 2022. Following the application by Diurnal to the London Stock Exchange, the cancellation of admission to trading of Diurnal Shares on AIM is expected to be effective as of 7.00 a.m. tomorrow, November 2, 2022.공고 • Oct 29Diurnal Group Shares to Cancel of Admission to Trade on AIM, Effective November 02Diurnal Group plc confirmed that last day of dealings in, or for registrations of transfers of, Diurnal Shareswill be 31 October 2022 and the Scheme Record Time will be 6.00 p.m. 31 October 2022. Scheme Shareholders on Diurnal's register of members at the Scheme Record Time will, upon the Scheme becoming Effective, be entitled to receive the consideration under the Scheme. Dealings in Diurnal Shares on AIM will be suspended from 7:30 a.m. on 1 November 2022. The suspension is made pursuant to Diurnal's application to the London Stock Exchange and is being effected as part of the Scheme. It is expected that, subject to the Scheme becoming Effective on 1 November 2022, the cancellation of admission to trading of Diurnal Shares on AIM will take effect from 7:00 a.m. on 2 November 2022.공고 • Oct 22Diurnal Group Provides an Update on Delisting of Its SharesThe board of Diurnal Group plc announced that, at the Court Meeting and General Meeting (together, the "Meetings") each held earlier on October 21, 2022, the requisite majorities of Scheme Shareholders voted to approve the Scheme at the Court Meeting and the requisite majority of Diurnal Shareholders voted to pass the Resolution in connection with the implementation of the Scheme, including the amendment to Diurnal's articles of association, at the General Meeting. The expected effective date of scheme is November 1, 2022 (D). The expected time of cancellation of admission to trading of Diurnal shares will be 7.00 a.m. on November 2, 2022 (D+1).공고 • Oct 07Diurnal Group plc Announces AWMSG Recommends Efmody for CAH within NHS WalesDiurnal Group plc announced that the All Wales Medicines Strategy Group (AWMSG) has recommended Efmody® (hydrocortisone modified-release hard capsules) as an option for restricted use to treat adolescents and adults with congenital adrenal hyperplasia (CAH) within NHS Wales. The AWMSG's recommendation means that Efmody® is available for use as a second-line treatment option in adolescents with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone; and as a third-line treatment in adults with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone and/or prednisolone. Diurnal will commercially roll-out Efmody® in Wales using its existing sales and marketing infrastructure and supply chain. Efmody® has been available for the treatment of CAH in the UK since launch in October 2021. Efmody® is licensed for the treatment of congenital adrenal hyperplasia in adolescents aged 12 years and older and in adults in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA).공고 • Sep 01Diurnal Group plc to Report Fiscal Year 2022 Results on Sep 14, 2022Diurnal Group plc announced that they will report fiscal year 2022 results on Sep 14, 2022더 많은 업데이트 보기Recent updates공고 • Nov 03Diurnal Group Announces Delisting and Cancellation of Trading of SharesFurther to the announcement made by the boards of Neurocrine and Diurnal Group plc on November 1, 2022 that the Scheme has become Effective in accordance with its terms, Diurnal confirmed that the admission to trading of Diurnal Shares on the AIM Market of the London Stock Exchange has been cancelled with effect from 7:00 a.m. on November 2, 2022.공고 • Nov 02Diurnal Group plc Shares Suspend from AIMTrading in Diurnal Group plc shares on AIM was suspended with effect from 7.30 a.m. today, November 1, 2022. Following the application by Diurnal to the London Stock Exchange, the cancellation of admission to trading of Diurnal Shares on AIM is expected to be effective as of 7.00 a.m. tomorrow, November 2, 2022.공고 • Oct 29Diurnal Group Shares to Cancel of Admission to Trade on AIM, Effective November 02Diurnal Group plc confirmed that last day of dealings in, or for registrations of transfers of, Diurnal Shareswill be 31 October 2022 and the Scheme Record Time will be 6.00 p.m. 31 October 2022. Scheme Shareholders on Diurnal's register of members at the Scheme Record Time will, upon the Scheme becoming Effective, be entitled to receive the consideration under the Scheme. Dealings in Diurnal Shares on AIM will be suspended from 7:30 a.m. on 1 November 2022. The suspension is made pursuant to Diurnal's application to the London Stock Exchange and is being effected as part of the Scheme. It is expected that, subject to the Scheme becoming Effective on 1 November 2022, the cancellation of admission to trading of Diurnal Shares on AIM will take effect from 7:00 a.m. on 2 November 2022.공고 • Oct 22Diurnal Group Provides an Update on Delisting of Its SharesThe board of Diurnal Group plc announced that, at the Court Meeting and General Meeting (together, the "Meetings") each held earlier on October 21, 2022, the requisite majorities of Scheme Shareholders voted to approve the Scheme at the Court Meeting and the requisite majority of Diurnal Shareholders voted to pass the Resolution in connection with the implementation of the Scheme, including the amendment to Diurnal's articles of association, at the General Meeting. The expected effective date of scheme is November 1, 2022 (D). The expected time of cancellation of admission to trading of Diurnal shares will be 7.00 a.m. on November 2, 2022 (D+1).공고 • Oct 07Diurnal Group plc Announces AWMSG Recommends Efmody for CAH within NHS WalesDiurnal Group plc announced that the All Wales Medicines Strategy Group (AWMSG) has recommended Efmody® (hydrocortisone modified-release hard capsules) as an option for restricted use to treat adolescents and adults with congenital adrenal hyperplasia (CAH) within NHS Wales. The AWMSG's recommendation means that Efmody® is available for use as a second-line treatment option in adolescents with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone; and as a third-line treatment in adults with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone and/or prednisolone. Diurnal will commercially roll-out Efmody® in Wales using its existing sales and marketing infrastructure and supply chain. Efmody® has been available for the treatment of CAH in the UK since launch in October 2021. Efmody® is licensed for the treatment of congenital adrenal hyperplasia in adolescents aged 12 years and older and in adults in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA).공고 • Sep 01Diurnal Group plc to Report Fiscal Year 2022 Results on Sep 14, 2022Diurnal Group plc announced that they will report fiscal year 2022 results on Sep 14, 2022공고 • Aug 31+ 1 more updateNeurocrine Biosciences, Inc. (NasdaqGS:NBIX) agreed to acquire Diurnal Group plc (AIM:DNL) for £46.8 million.Neurocrine Biosciences, Inc. (NasdaqGS:NBIX) agreed to acquire Diurnal Group plc (AIM:DNL) for £46.8 million on August 30, 2022. Under the terms, Diurnal shareholders shall be entitled to receive 27.5 pence in cash for each Diurnal ShareThe cash consideration payable under the Acquisition is being financed by cash on the balance sheet of Neurocrine. Transaction is conditional on the approval of Diurnal Shareholders. John Craven and Toby Rolls of Smith Square Partners LLP acted as financial advisor to Neurocrine Biosciences, Inc. Freddy Crossley, Emma Earl, Mark Rogers and Rupert Dearden acted as financial advisor to Diurnal. Cooley (UK) LLP acted as legal advisor to Neurocrine Biosciences, Inc. and Eversheds Sutherland (International) LLP acted legal advisor to Diurnal.Breakeven Date Change • Jul 01Forecast to breakeven in 2025The 4 analysts covering Diurnal Group expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of UK£7.56m in 2025. Average annual earnings growth of 59% is required to achieve expected profit on schedule.공고 • Jun 02Diurnal Group plc announces First Patient Dosed in Pivotal Phase 3 Connect Clinical Trial for Us and Japanese MarketsDiurnal Group plc announced that the first patient has been dosed in its Phase 3 pivotal clinical trial ofhydrocortisone modified-release hard capsules (DNL-0200 -approved in Europe and the UK under the commercial name Efmody®)for adults with congenital adrenal hyperplasia (CAH). The pivotal Phase 3 randomised, double-blind, active-controlled, clinical trial, known as CONnECT, is evaluating the efficacy, safety and tolerability ofmodified-release hydrocortisonecompared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with CAH. The pivotal studyfor key US and Japan marketsworth together in excess of $100m per annum will recruit up to 150 subjects with CAH who will be treated for a period of 52 weeks in centres across Japan, the US, France, and Turkey. The study is anticipated to take up to one year to recruit all patients, with subsequent data readout anticipated in 2024. The study is being conducted under a Special Protocol Assessment (SPA) that has been agreed with the US FDA. The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that would support the regulatory submission for drug approval. DNL-0200 is a preparation of hydrocortisone that has been specifically designed for patients with diseases of cortisol deficiency such as CAH and is currently approved as the only near physiological cortisol replacement treatment for CAH in Europe and the UK.공고 • May 23Diurnal Group plc Announces Presentation At European Congress of EndocrinologyDiurnal Group plc, the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, will be presenting research findings on the treatment and management of congenital adrenal hyperplasia (CAH) at this year's European Congress of Endocrinology, which takes place 21-24 May 2022 in Milan, Italy. Over the four-day meeting, the following topics will be presented: Findings in fertility inCAH patients on Modified-Release Hydrocortisone Capsules (MR-HC, Efmody®). Findings on control of CAH on MR-HC. The burden of illness associated with adolescent and adult CAH. Literature review onsupraphysiological glucocorticoiddosing in CAH. MR-HC effects on mineralocorticoid requirements. CAH occurs when the production of cortisol from the adrenal gland is limited due to a genetic deficiency. CAH is associated with over-production of male sex hormones resulting in ambiguous genitalia at birth, precocious sexual development, infertility in men and women, and increased mortality through adrenal crisis. Around 450,000 people globally are estimated to be living with a CAH disorder yet there is no standard treatment. Instead, a variety of steroids are used but data shows around two thirds of people living with CAH still have problems with disease control.Board Change • Apr 27Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent Non-Executive Director Jean-Michel Yves Cossery was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.공고 • Apr 04+ 1 more updateDiurnal Group plc Announces Executive ChangesDiurnal Group plc announced that following 14 years with the Company, Martin Whitaker has decided to step down as Chief Executive Officer (CEO) and a member of the Board of Diurnal, with immediate effect, to enable him to pursue other business opportunities. Richard Bungay, currently the Company's Chief Financial Officer (CFO), who has been with the Company for more than five years, will immediately assume the role of Interim CEO until a successor is appointed. Additionally, David Bevan, who was appointed Interim Head of Commercial in November2021, has been promoted to the newly created role of Chief Business Officer. David has over 30 years of pharmaceutical expertise with a broad base of general management, sales, marketing and commercial experience, in large and medium-sized pharmaceutical companies with Global, EU and UK responsibility.공고 • Mar 10Diurnal Group plc Provides Update on Scottish Medicines ConsortiumDiurnal Group plc provided an update on the status of reimbursement of Efmody® (modified-release hydrocortisone) for NHS Scotland. The Company notes that, while Efmody® remains available to prescribe in Scotland, the Scottish Medicines Consortium (SMC) has announced that Efmody® has not been recommended for automatic reimbursement within NHS Scotland as a treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. Diurnal will generate further clinical and health-economic data to support a re-submission to the SMC at the earliest possible opportunity. Diurnal will continue to make Efmody available to patients in Scotland and is committed to patient access through a number of means including support for clinicians wishing to utilise Efmody® in their clinics. As a result of the SMC decision, Diurnal's Efmody® sales forecasts for the UK will be impacted reflecting the reliance of a number of healthcare clinical commissioning groups on the SMC assessment. However, the Board still expects strong sales growth in total product sales in excess of 100% for the 12-month period ended 30 June 2022 compared to the prior period as the commercial roll out of Alkindi® and Efmody® continues across Europe.공고 • Mar 03Diurnal Group plc Updates on Oral Native TestosteroneDiurnal Group plc announces that it has received feedback from the US Food and Drug Administration for its native oral testosterone treatment in response to the Company's Investigational New Drug application submitted towards the end of January 2022. As announced in July 2020, the FDA has previously indicated that the registration programme for DNL-0300 for the treatment of male hypogonadism can progress via the 505(b)(2) regulatory pathway, which means potentially only two further clinical studies are required before filing for market approval via a New Drug Application: a Phase 1 multiple-ascending dose study followed by a single pivotal Phase 3 trial. In the latest feedback, the FDA has stated that Diurnal's Phase 1 study can proceed subject to a protocol modification, primarily relating to additional clinical safety data from the two lowest dose groups. Diurnal expects to file an amended protocol for the MAD study as soon as possible with a view to initiating dosing in second half of 2022. DNL-0300 will remain on partial clinical hold until the revised protocol has been agreed with the FDA.공고 • Feb 25Diurnal Group plc to Report First Half, 2022 Results on Mar 22, 2022Diurnal Group plc announced that they will report first half, 2022 results on Mar 22, 2022공고 • Feb 10Diurnal Group Announces First Patient Dosed in Phase 2 Clinical Trial with Modified-Release Hydrocortisone in Adults with Adrenal InsufficiencyDiurnal Group plc announced that the first patient has been dosed in its Phase 2 European clinical trial of modified-release hydrocortisone for a line extension in adrenal insufficiency. AI represents a significant market opportunity for the Company of approximately $1.9 billion across Europe and the UK. The Phase 2 study will evaluate the efficacy, safety and tolerability of modified-release hydrocortisone versus Plenadren in AI. The study will recruit up to 50 subjects with primary AI who will be followed for a period of 16 weeks across centres in Germany and the UK. The CHAMPAIN study is anticipated to take six months to complete with data readout expected in H2 2022. The results of the study will support the Company's discussions with both the European Medicines Agency and the UK Medicines and Healthcare Regulatory Agency to seek market authorisations for the product in adult AI in Europe and the UK. Modified-release hydrocortisone is a preparation of hydrocortisone that has been specifically designed for patients with diseases of cortisol deficiency such as AI and additionally the condition of congenital adrenal hyperplasia for which it is approved in Europe and the UK. AI is an orphan condition caused by inadequate production of steroid hormones in the cortex of the adrenal glands. AI can result in severe fatigue and, if left untreated, adrenal crisis that may be life threatening. AI is estimated to affect 298,000 patients in Europe and the UK.Breakeven Date Change • Jan 18No longer forecast to breakevenThe 5 analysts covering Diurnal Group no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of UK£12.4m in 2024. New consensus forecast suggests the company will make a loss of UK£18.0m in 2024.Breakeven Date Change • Dec 15No longer forecast to breakevenThe 5 analysts covering Diurnal Group no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of UK£12.4m in 2024. New consensus forecast suggests the company will make a loss of UK£12.0m in 2024.Breakeven Date Change • Sep 23Forecast to breakeven in 2024The 3 analysts covering Diurnal Group expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of UK£18.6m in 2024. Average annual earnings growth of 61% is required to achieve expected profit on schedule.Reported Earnings • Sep 15Full year 2021 earnings released: UK£0.073 loss per share (vs UK£0.043 loss in FY 2020)The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2021 results: Revenue: UK£4.37m (down 31% from FY 2020). Net loss: UK£10.0m (loss widened 147% from FY 2020).공고 • Sep 14Diurnal Group plc Announces Commercial Launch of Efmody in the UkDiurnal Group plc announced the commercial launch of Efmody (hydrocortisone modified-release hard capsules) in the United Kingdom as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH). The launch of Efmody® follows its approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain (England, Wales and Scotland) in July 2021. Consistent with the Company's European commercialisation strategy, Diurnal is marketing Efmody® in the UK with its own salesforce. In parallel to this launch and following the recent launch in Germany and Austria on 1 September, Diurnal is currently in discussions with various health authorities across the European Economic Area to ensure timely launches in other major European countries. Launch stocks of Efmody® have been manufactured in advance of the planned launches in order to provide timely availability of the product, utilising many aspects of the supply chain that have already been established by the Company for Alkindi.Recent Insider Transactions • Jul 16CFO, Company Secretary & Director recently sold €78k worth of stockOn the 13th of July, Richard Bungay sold around 106k shares on-market at roughly €0.74 per share. This was the largest sale by an insider in the last 3 months. Richard has been a seller over the last 12 months, reducing personal holdings by €72k.공고 • Jul 14Diurnal Group plc Receives Agreement from US FDA on Special Protocol Assessment for Chronocort®Diurnal Group plc announced 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.공고 • Jul 03Diurnal Group plc Announces Marketing Authorisation for Efmody in GB from MHRADiurnal Group plc 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 large 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 First Quarter 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.Breakeven Date Change • Jul 02Forecast to breakeven in 2024The 4 analysts covering Diurnal Group expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of UK£40.8m in 2024. Average annual earnings growth of 59% is required to achieve expected profit on schedule.공고 • May 29Diurnal Group plc Receives European Commission Receives Approval for EfmodyDiurnal Group plc announced the European Commission (EC) has approved the marketing authorization 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 Third Quarter 2021. The Company intends to mirror its strategy for Alkindi® (hydrocortisone granules in capsules for opening) by commercializing 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.Breakeven Date Change • May 28Forecast breakeven pushed back to 2024The 4 analysts covering Diurnal Group previously expected the company to break even in 2023. New consensus forecast suggests the company will make a profit of UK£23.2m in 2024. Average annual earnings growth of 65% is required to achieve expected profit on schedule.공고 • May 11Diurnal Group plc has completed a Follow-on Equity Offering in the amount of £1.996622 million.Diurnal Group plc has completed a Follow-on Equity Offering in the amount of £1.996622 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 2,852,317 Price\Range: £0.7 Transaction Features: Regulation S; Rights OfferingIs New 90 Day High Low • Mar 16New 90-day high: €0.77The company is up 45% from a price of €0.53 on 16 December 2020. Outperformed the German market which is up 9.0% over the last 90 days. Exceeded the Biotechs industry, which is down 2.0% over the same period.Reported Earnings • Feb 25First half 2021 earnings released: UK£0.037 loss per share (vs UK£0.047 loss in 1H 2020)The company reported a soft first half result with increased losses and weaker control over costs, although revenues improved. First half 2021 results: Revenue: UK£1.21m (up 5.8% from 1H 2020). Net loss: UK£4.66m (loss widened 16% from 1H 2020).공고 • Feb 24Diurnal Group plc Extends Its Distribution Arrangements with Consilient HealthDiurnal Group plc announced that it has extended its distribution arrangements with Consilient Health to include the distribution and marketing of Chronocort (modified-release hydrocortisone) in the Nordic region (consisting ofSweden, Norway, Denmark, Finland and Iceland). Under the terms of this agreement, Consilient Health, a pharmaceutical company with a track record in commercialising products for endocrinology, women's health and urology, will receive the exclusive rights to market and sell Chronocort® when approved, in the Nordics. The region represents a significant market opportunity for Diurnal, with around 2,300 adult patients suffering from congenital adrenal hyperplasia (CAH), providing an estimated total market opportunity for Chronocort of approximately €11.5 million per annum. Chronocort® is a modified-release preparation of hydrocortisone that is under review by the European Medicines Agency (EMA). Chronocort is given in a twice-a-day regimen to treat diseases of cortisol deficiency. If regulatory review is favourable, a marketing authorisation opinion for Chronocort approval in the European Economic Area is anticipated during first quarter of 2021.공고 • Feb 03Diurnal Group plc Publishes the Peer-Reviewed Results of the Phase 3 Clinical Trial and Extension Study for Chronocort®Diurnal Group plc announced that the endocrinologist-focused Journal of Clinical Endocrinology and Metabolism ("JCEM") has published the peer-reviewed results of the Company's Phase 3 clinical trial and extension study for Chronocort® (hydrocortisone modified-release hard capsules) in patients with the rare condition congenital adrenal hyperplasia (CAH). The Company's Phase 3 study was conducted in a total of 122 patients enrolled across 11 clinical sites. Data are also presented from an open-label safety extension study for patients completing treatment in the Phase 3 study. These data assessed the impact of treatment with Chronocort® over a further period of 18 months. A significant proportion of patients eligible to enter the follow-on study did so, and patient retention rates in this study remain high. As previously announced, the Phase 3 study results published by the JCEM found that although the standard-deviation-score-focused primary endpoint of the study was missed, Chronocort® improved morning and early afternoon biochemical control for adults with CAH over standard glucocorticoid therapy. In the safety extension study, biochemical control was sustained for 18 months on median hydrocortisone doses in the range recommended for cortisol replacement therapy and lower than glucocorticoid doses normally used in the treatment of CAH. The manuscript concludes that Chronocort® provides a well-tolerated and practical twice-daily treatment regimen for CAH in adults, due to a deficiency of 21-hydroxylase.공고 • Jan 29Citrine Medicine Announces Strategic Partnership to Bring Alkindi to China for Use in Pediatric Congenital Adrenal HyperplasiaCitrine Medicine announced that it has entered into a licensing agreement with Diurnal Group plc. The deal provides Citrine with exclusive rights to develop, register and commercialize Alkindi in the Greater China market. Citrine is leveraging China's expedited regulatory pathways to achieve rapid approval of rare disease drugs. They are also building an integrated platform that can support scalable commercialization via key opinion leader engagement, diagnosis and treatment of rare diseases patients, disease advocacy, and patient financial support. Citrine is initially focused on rare diseases in neurology, hepatology, nephrology, endocrine, metabolic and pediatric oncology. By licensing the rights to Alkindi, Citrine aims to bring the first clinically validated pediatric treatment for congenital adrenal hyperplasia (CAH), a group of genetic conditions that limit hormone production in the adrenal glands, to China. It is estimated that CAH occurs in 1 in 6,084 births in China. CAH was identified as a rare disease by the Chinese health authorities in May 2018.공고 • Jan 28Diurnal Group plc Enters into an Exclusive Licence Agreement for Its Product, Alkindi with Citrine Medicine, IncDiurnal Group plc announced that it has entered into an exclusive licence agreement for its product, Alkindi (hydrocortisone granules in capsules for opening), with the specialty pharmaceutical company, Citrine Medicine Inc. covering China, Hong Kong, Taiwan and Macau. Under the terms of the licence agreement, Diurnal will receive a non-refundable upfront payment of $0.5 million and will receive $12.75m in additional cash payments upon achievement of certain regulatory milestones and sales milestones based on annual sales thresholds. Diurnal will receive tiered royalties on sales ranging from low to mid double-digits. Citrine is a therapeutics platform company focused on the Greater China market that was co-founded by Vivo Capital, F-Prime Capital and Eight Roads Ventures. Citrine is focused on creating a therapeutic platform to deliver rare disease drugs to the Chinese market and to develop the first ever rare disease ecosystem in the country. Citrine will be responsible for obtaining registration for Alkindi® as a treatment for paediatric patients in China and for all commercialisation activities, including pricing and reimbursement. Citrine will initially utilise product from Diurnal's European supply chain, with an option to establish its own supply chain in China in the future. It is estimated that congenital adrenal hyperplasia (CAH) occurs in 1 in 6,084 births in China1. CAH is a group of genetic conditions that limit hormone production in the adrenal glands and was identified a rare disease by the Chinese health authorities in May 2018.Is New 90 Day High Low • Jan 15New 90-day high: €0.72The company is up 8.0% from its price of €0.67 on 16 October 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.64 per share.공고 • Jan 14+ 1 more updateDiurnal Group plc Announces It Has Extended Its Exclusive Licence Arrangement for Alkindi with Eton Pharmaceuticals, IncDiurnal Group plc announced that it has extended its exclusive licence arrangement for Alkindi® (hydrocortisone granules in capsules for opening) with Eton Pharmaceuticals, Inc. to include Canada. In addition, the Company has been granted a key Canadian patent claiming method of treatment for Alkindi®. In March 2020, Diurnal entered into an exclusive licence agreement for Alkindi® Sprinkle (as Alkindi® is known in the US) in the US with Eton, a specialty pharmaceutical company focused on developing and commercialising innovative treatments for rare paediatric diseases. Following approval by the US Food and Drug Administration, Eton announced in November 2020 that Alkindi® Sprinkle is available for sale and distribution in the US. Under the terms of the new licence agreement, Eton will be responsible for obtaining registration for Alkindi® in Canada for the treatment of paediatric patients suffering from adrenal insufficiency and for all commercialisation activities, including pricing and reimbursement. Eton will initially utilise product from Diurnal's European supply chain, with an option to establish its own supply chain in the future. Diurnal will receive a royalty on future sales in Canada. CA2854717, entitled "Treatment of Adrenal Insufficiency in Children", is a patent disclosing and claiming method of treatment for Alkindi® and, together with granted Canadian patent (No: CA2909060 claiming the composition of Alkindi®), provides patent exclusivity in the territory until 2034. The corresponding US patents have already been granted.공고 • Jan 12+ 1 more updateDiurnal Group plc Announces Chronocort MAA Submitted to the UK MHRADiurnal Group plc announced that an 'in flight' Market Authorisation Application (MAA) has been submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Chronocort® (modified-release hydrocortisone) as a treatment for adult and adolescent patients with the rare condition congenital adrenal hyperplasia (CAH) in Great Britain (England, Wales and Scotland). The MAA submission follows MHRA guidance following the end of the Brexit Transition Period and follows submission of an MAA to the European Medicines Agency (EMA) in December 2019, which was subsequently validated by the EMA in April 2020 and has continued along its planned review path with a marketing authorisation opinion for Chronocort® approval in the European Economic Area anticipated in first quarter of 2021. The submission for the MHRA is based on the same application submitted to the EMA in December 2019, including detailed analysis of data from the Company's Phase 3 study, the largest ever interventional clinical trial in CAH, an open-label safety extension study of Chronocort® and written formal Scientific Advice received in April 2019 confirming the clinical and regulatory pathway for Chronocort® as a treatment for patients with CAH. In parallel with the MHRA submission, Diurnal will seek confirmation of British Orphan Drug Status for Chronocort® in CAH, which requires the Company to demonstrate significant clinical benefit for the product compared to existing therapies. Should Chronocort® be approved, it will provide the potential for life-long treatment across Europe, with patients commencing treatment with Alkindi® (hydrocortisone granules in capsules for opening), the Company's approved paediatric product, transitioning to Chronocort® in adolescence and continuing with Chronocort® treatment into later life.Is New 90 Day High Low • Dec 24New 90-day low: €0.48The company is down 41% from its price of €0.81 on 25 September 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.50 per share.Is New 90 Day High Low • Nov 20New 90-day low: €0.54The company is down 29% from its price of €0.76 on 21 August 2020. The German market is up 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.48 per share.공고 • Nov 12Diurnal Group plc to Report First Half, 2021 Results on Feb 23, 2021Diurnal Group plc announced that they will report first half, 2021 results on Feb 23, 2021공고 • Oct 11+ 1 more updateDiurnal Group plc has completed a Follow-on Equity Offering in the amount of £8 million.Diurnal Group plc has completed a Follow-on Equity Offering in the amount of £8 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 13,333,333 Price\Range: £0.6 Transaction Features: Regulation S; Subsequent Direct ListingAnalyst Estimate Surprise Post Earnings • Oct 10Annual earnings released: Revenue beats expectationsAnnual revenue exceeded analyst estimates by 164% at UK£6.31m. Revenue is expected to shrink by 3.7% over the next year, compared to a 280% growth forecast for the Biotechs industry in Germany.Reported Earnings • Oct 10Full year earnings released - €0.043 loss per shareOver the last 12 months the company has reported total losses of UK£4.07m, with losses narrowing by 67% from the prior year. Total revenue was UK£6.31m over the last 12 months, up by UK£5.26m from the prior year.공고 • Oct 04Diurnal Group plc Announces Alkindi Sprinkle Approved by US FDADiurnal Group plc announced that the US Food and Drug Administration (FDA) has approved Alkindi® Sprinkle (hydrocortisone oral granules) as replacement therapy in paediatric patients with adrenocortical insufficiency (AI). This approval is based on a positive review of data from the Company's comprehensive development programme for Alkindi® Sprinkle, including a study to demonstrate bioequivalence with the US reference product, as well as a safety evaluation and tolerability extension study in Europe, which provides valuable long-term exposure data in support of market access in the US. Alkindi® Sprinkle is a patented, oral, immediate-release formulation of hydrocortisone granules in capsules designed for children. Alkindi® Sprinkle comes in dose strengths consistent with age-appropriate dosing in children. This therapeutic approach has the potential to help patients less than seventeen years of age suffering from diseases due to cortisol deficiency in the US. Diurnal has partnered with Eton Pharmaceuticals for the commercialisation activities of Alkindi® Sprinkle in the US, including pricing and reimbursement. Eton will initially use product from Diurnal's European Alkindi® supply chain, with an option to establish its own supply chain in the US in the future. As previously announced, under the terms of the licensing agreement, Diurnal will receive a $2.5 million cash milestone payment upon first commercial sale of Alkindi® Sprinkle in the US following grant of Orphan Drug Status. The Company will also receive a tiered royalty on sales ranging from low double-digits to high teens and is due tiered sales-based milestone payments of up to $45 million in aggregate subject to annual sales thresholds. These payments are in addition to the upfront payment of $5.0 million received by Diurnal upon signing the contract with Eton in March this year.주주 수익률4UUDE BiotechsDE 시장7D1.4%-3.3%-0.2%1Y-59.1%4.2%-0.9%전체 주주 수익률 보기수익률 대 산업: 4UU은 지난 1년 동안 6.7%의 수익을 기록한 German Biotechs 산업보다 저조한 성과를 냈습니다.수익률 대 시장: 4UU은 지난 1년 동안 0.6%를 기록한 German 시장보다 저조한 성과를 냈습니다.주가 변동성Is 4UU's price volatile compared to industry and market?4UU volatility4UU Average Weekly Movement51.5%Biotechs Industry Average Movement7.8%Market Average Movement5.5%10% most volatile stocks in DE Market12.9%10% least volatile stocks in DE Market2.8%안정적인 주가: 4UU의 주가는 지난 3개월 동안 German 시장보다 변동성이 컸습니다.시간에 따른 변동성: 4UU의 주간 변동성은 지난 1년간 28%에서 52%로 증가했습니다.회사 소개설립직원 수CEO웹사이트201533Richard Bungaywww.diurnal.co.uk더 보기Diurnal Group plc 기초 지표 요약Diurnal Group의 순이익과 매출은 시가총액과 어떻게 비교됩니까?4UU 기초 통계시가총액€47.74m순이익 (TTM)-€18.98m매출 (TTM)€5.36m9.2x주가매출비율(P/S)-2.6x주가수익비율(P/E)4UU는 고평가되어 있습니까?공정 가치 및 평가 분석 보기순이익 및 매출최근 실적 보고서(TTM)의 주요 수익성 지표4UU 손익계산서 (TTM)매출UK£4.68m매출원가UK£1.02m총이익UK£3.66m기타 비용UK£20.23m순이익-UK£16.57m최근 보고된 실적Jun 30, 2022다음 실적 발표일해당 없음주당순이익(EPS)-0.095총이익률78.16%순이익률-353.76%부채/자본 비율0.0%4UU의 장기 실적은 어땠습니까?과거 실적 및 비교 보기View Valuation기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2022/11/03 02:56종가2022/11/01 00:00수익2022/06/30연간 수익2022/06/30데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델의 세부 정보는 당사의 GitHub 페이지에서 확인하실 수 있습니다. 또한 보고서 사용 방법에 대한 가이드와 YouTube 튜토리얼도 제공하고 있습니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Diurnal Group plc는 2명의 분석가가 다루고 있습니다. 이 중 2명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Michael FosterHardman & Co.James OrsborneStifel, Equities Research
공고 • Nov 03Diurnal Group Announces Delisting and Cancellation of Trading of SharesFurther to the announcement made by the boards of Neurocrine and Diurnal Group plc on November 1, 2022 that the Scheme has become Effective in accordance with its terms, Diurnal confirmed that the admission to trading of Diurnal Shares on the AIM Market of the London Stock Exchange has been cancelled with effect from 7:00 a.m. on November 2, 2022.
공고 • Nov 02Diurnal Group plc Shares Suspend from AIMTrading in Diurnal Group plc shares on AIM was suspended with effect from 7.30 a.m. today, November 1, 2022. Following the application by Diurnal to the London Stock Exchange, the cancellation of admission to trading of Diurnal Shares on AIM is expected to be effective as of 7.00 a.m. tomorrow, November 2, 2022.
공고 • Oct 29Diurnal Group Shares to Cancel of Admission to Trade on AIM, Effective November 02Diurnal Group plc confirmed that last day of dealings in, or for registrations of transfers of, Diurnal Shareswill be 31 October 2022 and the Scheme Record Time will be 6.00 p.m. 31 October 2022. Scheme Shareholders on Diurnal's register of members at the Scheme Record Time will, upon the Scheme becoming Effective, be entitled to receive the consideration under the Scheme. Dealings in Diurnal Shares on AIM will be suspended from 7:30 a.m. on 1 November 2022. The suspension is made pursuant to Diurnal's application to the London Stock Exchange and is being effected as part of the Scheme. It is expected that, subject to the Scheme becoming Effective on 1 November 2022, the cancellation of admission to trading of Diurnal Shares on AIM will take effect from 7:00 a.m. on 2 November 2022.
공고 • Oct 22Diurnal Group Provides an Update on Delisting of Its SharesThe board of Diurnal Group plc announced that, at the Court Meeting and General Meeting (together, the "Meetings") each held earlier on October 21, 2022, the requisite majorities of Scheme Shareholders voted to approve the Scheme at the Court Meeting and the requisite majority of Diurnal Shareholders voted to pass the Resolution in connection with the implementation of the Scheme, including the amendment to Diurnal's articles of association, at the General Meeting. The expected effective date of scheme is November 1, 2022 (D). The expected time of cancellation of admission to trading of Diurnal shares will be 7.00 a.m. on November 2, 2022 (D+1).
공고 • Oct 07Diurnal Group plc Announces AWMSG Recommends Efmody for CAH within NHS WalesDiurnal Group plc announced that the All Wales Medicines Strategy Group (AWMSG) has recommended Efmody® (hydrocortisone modified-release hard capsules) as an option for restricted use to treat adolescents and adults with congenital adrenal hyperplasia (CAH) within NHS Wales. The AWMSG's recommendation means that Efmody® is available for use as a second-line treatment option in adolescents with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone; and as a third-line treatment in adults with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone and/or prednisolone. Diurnal will commercially roll-out Efmody® in Wales using its existing sales and marketing infrastructure and supply chain. Efmody® has been available for the treatment of CAH in the UK since launch in October 2021. Efmody® is licensed for the treatment of congenital adrenal hyperplasia in adolescents aged 12 years and older and in adults in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA).
공고 • Sep 01Diurnal Group plc to Report Fiscal Year 2022 Results on Sep 14, 2022Diurnal Group plc announced that they will report fiscal year 2022 results on Sep 14, 2022
공고 • Nov 03Diurnal Group Announces Delisting and Cancellation of Trading of SharesFurther to the announcement made by the boards of Neurocrine and Diurnal Group plc on November 1, 2022 that the Scheme has become Effective in accordance with its terms, Diurnal confirmed that the admission to trading of Diurnal Shares on the AIM Market of the London Stock Exchange has been cancelled with effect from 7:00 a.m. on November 2, 2022.
공고 • Nov 02Diurnal Group plc Shares Suspend from AIMTrading in Diurnal Group plc shares on AIM was suspended with effect from 7.30 a.m. today, November 1, 2022. Following the application by Diurnal to the London Stock Exchange, the cancellation of admission to trading of Diurnal Shares on AIM is expected to be effective as of 7.00 a.m. tomorrow, November 2, 2022.
공고 • Oct 29Diurnal Group Shares to Cancel of Admission to Trade on AIM, Effective November 02Diurnal Group plc confirmed that last day of dealings in, or for registrations of transfers of, Diurnal Shareswill be 31 October 2022 and the Scheme Record Time will be 6.00 p.m. 31 October 2022. Scheme Shareholders on Diurnal's register of members at the Scheme Record Time will, upon the Scheme becoming Effective, be entitled to receive the consideration under the Scheme. Dealings in Diurnal Shares on AIM will be suspended from 7:30 a.m. on 1 November 2022. The suspension is made pursuant to Diurnal's application to the London Stock Exchange and is being effected as part of the Scheme. It is expected that, subject to the Scheme becoming Effective on 1 November 2022, the cancellation of admission to trading of Diurnal Shares on AIM will take effect from 7:00 a.m. on 2 November 2022.
공고 • Oct 22Diurnal Group Provides an Update on Delisting of Its SharesThe board of Diurnal Group plc announced that, at the Court Meeting and General Meeting (together, the "Meetings") each held earlier on October 21, 2022, the requisite majorities of Scheme Shareholders voted to approve the Scheme at the Court Meeting and the requisite majority of Diurnal Shareholders voted to pass the Resolution in connection with the implementation of the Scheme, including the amendment to Diurnal's articles of association, at the General Meeting. The expected effective date of scheme is November 1, 2022 (D). The expected time of cancellation of admission to trading of Diurnal shares will be 7.00 a.m. on November 2, 2022 (D+1).
공고 • Oct 07Diurnal Group plc Announces AWMSG Recommends Efmody for CAH within NHS WalesDiurnal Group plc announced that the All Wales Medicines Strategy Group (AWMSG) has recommended Efmody® (hydrocortisone modified-release hard capsules) as an option for restricted use to treat adolescents and adults with congenital adrenal hyperplasia (CAH) within NHS Wales. The AWMSG's recommendation means that Efmody® is available for use as a second-line treatment option in adolescents with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone; and as a third-line treatment in adults with CAH not adequately controlled on maximum guideline doses of immediate-release hydrocortisone and/or prednisolone. Diurnal will commercially roll-out Efmody® in Wales using its existing sales and marketing infrastructure and supply chain. Efmody® has been available for the treatment of CAH in the UK since launch in October 2021. Efmody® is licensed for the treatment of congenital adrenal hyperplasia in adolescents aged 12 years and older and in adults in Great Britain by the Medicines and Healthcare products Regulatory Agency (MHRA).
공고 • Sep 01Diurnal Group plc to Report Fiscal Year 2022 Results on Sep 14, 2022Diurnal Group plc announced that they will report fiscal year 2022 results on Sep 14, 2022
공고 • Aug 31+ 1 more updateNeurocrine Biosciences, Inc. (NasdaqGS:NBIX) agreed to acquire Diurnal Group plc (AIM:DNL) for £46.8 million.Neurocrine Biosciences, Inc. (NasdaqGS:NBIX) agreed to acquire Diurnal Group plc (AIM:DNL) for £46.8 million on August 30, 2022. Under the terms, Diurnal shareholders shall be entitled to receive 27.5 pence in cash for each Diurnal ShareThe cash consideration payable under the Acquisition is being financed by cash on the balance sheet of Neurocrine. Transaction is conditional on the approval of Diurnal Shareholders. John Craven and Toby Rolls of Smith Square Partners LLP acted as financial advisor to Neurocrine Biosciences, Inc. Freddy Crossley, Emma Earl, Mark Rogers and Rupert Dearden acted as financial advisor to Diurnal. Cooley (UK) LLP acted as legal advisor to Neurocrine Biosciences, Inc. and Eversheds Sutherland (International) LLP acted legal advisor to Diurnal.
Breakeven Date Change • Jul 01Forecast to breakeven in 2025The 4 analysts covering Diurnal Group expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of UK£7.56m in 2025. Average annual earnings growth of 59% is required to achieve expected profit on schedule.
공고 • Jun 02Diurnal Group plc announces First Patient Dosed in Pivotal Phase 3 Connect Clinical Trial for Us and Japanese MarketsDiurnal Group plc announced that the first patient has been dosed in its Phase 3 pivotal clinical trial ofhydrocortisone modified-release hard capsules (DNL-0200 -approved in Europe and the UK under the commercial name Efmody®)for adults with congenital adrenal hyperplasia (CAH). The pivotal Phase 3 randomised, double-blind, active-controlled, clinical trial, known as CONnECT, is evaluating the efficacy, safety and tolerability ofmodified-release hydrocortisonecompared with immediate-release hydrocortisone replacement therapy in participants aged 16-years and over with CAH. The pivotal studyfor key US and Japan marketsworth together in excess of $100m per annum will recruit up to 150 subjects with CAH who will be treated for a period of 52 weeks in centres across Japan, the US, France, and Turkey. The study is anticipated to take up to one year to recruit all patients, with subsequent data readout anticipated in 2024. The study is being conducted under a Special Protocol Assessment (SPA) that has been agreed with the US FDA. The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that would support the regulatory submission for drug approval. DNL-0200 is a preparation of hydrocortisone that has been specifically designed for patients with diseases of cortisol deficiency such as CAH and is currently approved as the only near physiological cortisol replacement treatment for CAH in Europe and the UK.
공고 • May 23Diurnal Group plc Announces Presentation At European Congress of EndocrinologyDiurnal Group plc, the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, will be presenting research findings on the treatment and management of congenital adrenal hyperplasia (CAH) at this year's European Congress of Endocrinology, which takes place 21-24 May 2022 in Milan, Italy. Over the four-day meeting, the following topics will be presented: Findings in fertility inCAH patients on Modified-Release Hydrocortisone Capsules (MR-HC, Efmody®). Findings on control of CAH on MR-HC. The burden of illness associated with adolescent and adult CAH. Literature review onsupraphysiological glucocorticoiddosing in CAH. MR-HC effects on mineralocorticoid requirements. CAH occurs when the production of cortisol from the adrenal gland is limited due to a genetic deficiency. CAH is associated with over-production of male sex hormones resulting in ambiguous genitalia at birth, precocious sexual development, infertility in men and women, and increased mortality through adrenal crisis. Around 450,000 people globally are estimated to be living with a CAH disorder yet there is no standard treatment. Instead, a variety of steroids are used but data shows around two thirds of people living with CAH still have problems with disease control.
Board Change • Apr 27Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 5 non-independent directors. Independent Non-Executive Director Jean-Michel Yves Cossery was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
공고 • Apr 04+ 1 more updateDiurnal Group plc Announces Executive ChangesDiurnal Group plc announced that following 14 years with the Company, Martin Whitaker has decided to step down as Chief Executive Officer (CEO) and a member of the Board of Diurnal, with immediate effect, to enable him to pursue other business opportunities. Richard Bungay, currently the Company's Chief Financial Officer (CFO), who has been with the Company for more than five years, will immediately assume the role of Interim CEO until a successor is appointed. Additionally, David Bevan, who was appointed Interim Head of Commercial in November2021, has been promoted to the newly created role of Chief Business Officer. David has over 30 years of pharmaceutical expertise with a broad base of general management, sales, marketing and commercial experience, in large and medium-sized pharmaceutical companies with Global, EU and UK responsibility.
공고 • Mar 10Diurnal Group plc Provides Update on Scottish Medicines ConsortiumDiurnal Group plc provided an update on the status of reimbursement of Efmody® (modified-release hydrocortisone) for NHS Scotland. The Company notes that, while Efmody® remains available to prescribe in Scotland, the Scottish Medicines Consortium (SMC) has announced that Efmody® has not been recommended for automatic reimbursement within NHS Scotland as a treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. Diurnal will generate further clinical and health-economic data to support a re-submission to the SMC at the earliest possible opportunity. Diurnal will continue to make Efmody available to patients in Scotland and is committed to patient access through a number of means including support for clinicians wishing to utilise Efmody® in their clinics. As a result of the SMC decision, Diurnal's Efmody® sales forecasts for the UK will be impacted reflecting the reliance of a number of healthcare clinical commissioning groups on the SMC assessment. However, the Board still expects strong sales growth in total product sales in excess of 100% for the 12-month period ended 30 June 2022 compared to the prior period as the commercial roll out of Alkindi® and Efmody® continues across Europe.
공고 • Mar 03Diurnal Group plc Updates on Oral Native TestosteroneDiurnal Group plc announces that it has received feedback from the US Food and Drug Administration for its native oral testosterone treatment in response to the Company's Investigational New Drug application submitted towards the end of January 2022. As announced in July 2020, the FDA has previously indicated that the registration programme for DNL-0300 for the treatment of male hypogonadism can progress via the 505(b)(2) regulatory pathway, which means potentially only two further clinical studies are required before filing for market approval via a New Drug Application: a Phase 1 multiple-ascending dose study followed by a single pivotal Phase 3 trial. In the latest feedback, the FDA has stated that Diurnal's Phase 1 study can proceed subject to a protocol modification, primarily relating to additional clinical safety data from the two lowest dose groups. Diurnal expects to file an amended protocol for the MAD study as soon as possible with a view to initiating dosing in second half of 2022. DNL-0300 will remain on partial clinical hold until the revised protocol has been agreed with the FDA.
공고 • Feb 25Diurnal Group plc to Report First Half, 2022 Results on Mar 22, 2022Diurnal Group plc announced that they will report first half, 2022 results on Mar 22, 2022
공고 • Feb 10Diurnal Group Announces First Patient Dosed in Phase 2 Clinical Trial with Modified-Release Hydrocortisone in Adults with Adrenal InsufficiencyDiurnal Group plc announced that the first patient has been dosed in its Phase 2 European clinical trial of modified-release hydrocortisone for a line extension in adrenal insufficiency. AI represents a significant market opportunity for the Company of approximately $1.9 billion across Europe and the UK. The Phase 2 study will evaluate the efficacy, safety and tolerability of modified-release hydrocortisone versus Plenadren in AI. The study will recruit up to 50 subjects with primary AI who will be followed for a period of 16 weeks across centres in Germany and the UK. The CHAMPAIN study is anticipated to take six months to complete with data readout expected in H2 2022. The results of the study will support the Company's discussions with both the European Medicines Agency and the UK Medicines and Healthcare Regulatory Agency to seek market authorisations for the product in adult AI in Europe and the UK. Modified-release hydrocortisone is a preparation of hydrocortisone that has been specifically designed for patients with diseases of cortisol deficiency such as AI and additionally the condition of congenital adrenal hyperplasia for which it is approved in Europe and the UK. AI is an orphan condition caused by inadequate production of steroid hormones in the cortex of the adrenal glands. AI can result in severe fatigue and, if left untreated, adrenal crisis that may be life threatening. AI is estimated to affect 298,000 patients in Europe and the UK.
Breakeven Date Change • Jan 18No longer forecast to breakevenThe 5 analysts covering Diurnal Group no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of UK£12.4m in 2024. New consensus forecast suggests the company will make a loss of UK£18.0m in 2024.
Breakeven Date Change • Dec 15No longer forecast to breakevenThe 5 analysts covering Diurnal Group no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of UK£12.4m in 2024. New consensus forecast suggests the company will make a loss of UK£12.0m in 2024.
Breakeven Date Change • Sep 23Forecast to breakeven in 2024The 3 analysts covering Diurnal Group expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of UK£18.6m in 2024. Average annual earnings growth of 61% is required to achieve expected profit on schedule.
Reported Earnings • Sep 15Full year 2021 earnings released: UK£0.073 loss per share (vs UK£0.043 loss in FY 2020)The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2021 results: Revenue: UK£4.37m (down 31% from FY 2020). Net loss: UK£10.0m (loss widened 147% from FY 2020).
공고 • Sep 14Diurnal Group plc Announces Commercial Launch of Efmody in the UkDiurnal Group plc announced the commercial launch of Efmody (hydrocortisone modified-release hard capsules) in the United Kingdom as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH). The launch of Efmody® follows its approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain (England, Wales and Scotland) in July 2021. Consistent with the Company's European commercialisation strategy, Diurnal is marketing Efmody® in the UK with its own salesforce. In parallel to this launch and following the recent launch in Germany and Austria on 1 September, Diurnal is currently in discussions with various health authorities across the European Economic Area to ensure timely launches in other major European countries. Launch stocks of Efmody® have been manufactured in advance of the planned launches in order to provide timely availability of the product, utilising many aspects of the supply chain that have already been established by the Company for Alkindi.
Recent Insider Transactions • Jul 16CFO, Company Secretary & Director recently sold €78k worth of stockOn the 13th of July, Richard Bungay sold around 106k shares on-market at roughly €0.74 per share. This was the largest sale by an insider in the last 3 months. Richard has been a seller over the last 12 months, reducing personal holdings by €72k.
공고 • Jul 14Diurnal Group plc Receives Agreement from US FDA on Special Protocol Assessment for Chronocort®Diurnal Group plc announced 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.
공고 • Jul 03Diurnal Group plc Announces Marketing Authorisation for Efmody in GB from MHRADiurnal Group plc 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 large 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 First Quarter 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.
Breakeven Date Change • Jul 02Forecast to breakeven in 2024The 4 analysts covering Diurnal Group expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of UK£40.8m in 2024. Average annual earnings growth of 59% is required to achieve expected profit on schedule.
공고 • May 29Diurnal Group plc Receives European Commission Receives Approval for EfmodyDiurnal Group plc announced the European Commission (EC) has approved the marketing authorization 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 Third Quarter 2021. The Company intends to mirror its strategy for Alkindi® (hydrocortisone granules in capsules for opening) by commercializing 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.
Breakeven Date Change • May 28Forecast breakeven pushed back to 2024The 4 analysts covering Diurnal Group previously expected the company to break even in 2023. New consensus forecast suggests the company will make a profit of UK£23.2m in 2024. Average annual earnings growth of 65% is required to achieve expected profit on schedule.
공고 • May 11Diurnal Group plc has completed a Follow-on Equity Offering in the amount of £1.996622 million.Diurnal Group plc has completed a Follow-on Equity Offering in the amount of £1.996622 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 2,852,317 Price\Range: £0.7 Transaction Features: Regulation S; Rights Offering
Is New 90 Day High Low • Mar 16New 90-day high: €0.77The company is up 45% from a price of €0.53 on 16 December 2020. Outperformed the German market which is up 9.0% over the last 90 days. Exceeded the Biotechs industry, which is down 2.0% over the same period.
Reported Earnings • Feb 25First half 2021 earnings released: UK£0.037 loss per share (vs UK£0.047 loss in 1H 2020)The company reported a soft first half result with increased losses and weaker control over costs, although revenues improved. First half 2021 results: Revenue: UK£1.21m (up 5.8% from 1H 2020). Net loss: UK£4.66m (loss widened 16% from 1H 2020).
공고 • Feb 24Diurnal Group plc Extends Its Distribution Arrangements with Consilient HealthDiurnal Group plc announced that it has extended its distribution arrangements with Consilient Health to include the distribution and marketing of Chronocort (modified-release hydrocortisone) in the Nordic region (consisting ofSweden, Norway, Denmark, Finland and Iceland). Under the terms of this agreement, Consilient Health, a pharmaceutical company with a track record in commercialising products for endocrinology, women's health and urology, will receive the exclusive rights to market and sell Chronocort® when approved, in the Nordics. The region represents a significant market opportunity for Diurnal, with around 2,300 adult patients suffering from congenital adrenal hyperplasia (CAH), providing an estimated total market opportunity for Chronocort of approximately €11.5 million per annum. Chronocort® is a modified-release preparation of hydrocortisone that is under review by the European Medicines Agency (EMA). Chronocort is given in a twice-a-day regimen to treat diseases of cortisol deficiency. If regulatory review is favourable, a marketing authorisation opinion for Chronocort approval in the European Economic Area is anticipated during first quarter of 2021.
공고 • Feb 03Diurnal Group plc Publishes the Peer-Reviewed Results of the Phase 3 Clinical Trial and Extension Study for Chronocort®Diurnal Group plc announced that the endocrinologist-focused Journal of Clinical Endocrinology and Metabolism ("JCEM") has published the peer-reviewed results of the Company's Phase 3 clinical trial and extension study for Chronocort® (hydrocortisone modified-release hard capsules) in patients with the rare condition congenital adrenal hyperplasia (CAH). The Company's Phase 3 study was conducted in a total of 122 patients enrolled across 11 clinical sites. Data are also presented from an open-label safety extension study for patients completing treatment in the Phase 3 study. These data assessed the impact of treatment with Chronocort® over a further period of 18 months. A significant proportion of patients eligible to enter the follow-on study did so, and patient retention rates in this study remain high. As previously announced, the Phase 3 study results published by the JCEM found that although the standard-deviation-score-focused primary endpoint of the study was missed, Chronocort® improved morning and early afternoon biochemical control for adults with CAH over standard glucocorticoid therapy. In the safety extension study, biochemical control was sustained for 18 months on median hydrocortisone doses in the range recommended for cortisol replacement therapy and lower than glucocorticoid doses normally used in the treatment of CAH. The manuscript concludes that Chronocort® provides a well-tolerated and practical twice-daily treatment regimen for CAH in adults, due to a deficiency of 21-hydroxylase.
공고 • Jan 29Citrine Medicine Announces Strategic Partnership to Bring Alkindi to China for Use in Pediatric Congenital Adrenal HyperplasiaCitrine Medicine announced that it has entered into a licensing agreement with Diurnal Group plc. The deal provides Citrine with exclusive rights to develop, register and commercialize Alkindi in the Greater China market. Citrine is leveraging China's expedited regulatory pathways to achieve rapid approval of rare disease drugs. They are also building an integrated platform that can support scalable commercialization via key opinion leader engagement, diagnosis and treatment of rare diseases patients, disease advocacy, and patient financial support. Citrine is initially focused on rare diseases in neurology, hepatology, nephrology, endocrine, metabolic and pediatric oncology. By licensing the rights to Alkindi, Citrine aims to bring the first clinically validated pediatric treatment for congenital adrenal hyperplasia (CAH), a group of genetic conditions that limit hormone production in the adrenal glands, to China. It is estimated that CAH occurs in 1 in 6,084 births in China. CAH was identified as a rare disease by the Chinese health authorities in May 2018.
공고 • Jan 28Diurnal Group plc Enters into an Exclusive Licence Agreement for Its Product, Alkindi with Citrine Medicine, IncDiurnal Group plc announced that it has entered into an exclusive licence agreement for its product, Alkindi (hydrocortisone granules in capsules for opening), with the specialty pharmaceutical company, Citrine Medicine Inc. covering China, Hong Kong, Taiwan and Macau. Under the terms of the licence agreement, Diurnal will receive a non-refundable upfront payment of $0.5 million and will receive $12.75m in additional cash payments upon achievement of certain regulatory milestones and sales milestones based on annual sales thresholds. Diurnal will receive tiered royalties on sales ranging from low to mid double-digits. Citrine is a therapeutics platform company focused on the Greater China market that was co-founded by Vivo Capital, F-Prime Capital and Eight Roads Ventures. Citrine is focused on creating a therapeutic platform to deliver rare disease drugs to the Chinese market and to develop the first ever rare disease ecosystem in the country. Citrine will be responsible for obtaining registration for Alkindi® as a treatment for paediatric patients in China and for all commercialisation activities, including pricing and reimbursement. Citrine will initially utilise product from Diurnal's European supply chain, with an option to establish its own supply chain in China in the future. It is estimated that congenital adrenal hyperplasia (CAH) occurs in 1 in 6,084 births in China1. CAH is a group of genetic conditions that limit hormone production in the adrenal glands and was identified a rare disease by the Chinese health authorities in May 2018.
Is New 90 Day High Low • Jan 15New 90-day high: €0.72The company is up 8.0% from its price of €0.67 on 16 October 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.64 per share.
공고 • Jan 14+ 1 more updateDiurnal Group plc Announces It Has Extended Its Exclusive Licence Arrangement for Alkindi with Eton Pharmaceuticals, IncDiurnal Group plc announced that it has extended its exclusive licence arrangement for Alkindi® (hydrocortisone granules in capsules for opening) with Eton Pharmaceuticals, Inc. to include Canada. In addition, the Company has been granted a key Canadian patent claiming method of treatment for Alkindi®. In March 2020, Diurnal entered into an exclusive licence agreement for Alkindi® Sprinkle (as Alkindi® is known in the US) in the US with Eton, a specialty pharmaceutical company focused on developing and commercialising innovative treatments for rare paediatric diseases. Following approval by the US Food and Drug Administration, Eton announced in November 2020 that Alkindi® Sprinkle is available for sale and distribution in the US. Under the terms of the new licence agreement, Eton will be responsible for obtaining registration for Alkindi® in Canada for the treatment of paediatric patients suffering from adrenal insufficiency and for all commercialisation activities, including pricing and reimbursement. Eton will initially utilise product from Diurnal's European supply chain, with an option to establish its own supply chain in the future. Diurnal will receive a royalty on future sales in Canada. CA2854717, entitled "Treatment of Adrenal Insufficiency in Children", is a patent disclosing and claiming method of treatment for Alkindi® and, together with granted Canadian patent (No: CA2909060 claiming the composition of Alkindi®), provides patent exclusivity in the territory until 2034. The corresponding US patents have already been granted.
공고 • Jan 12+ 1 more updateDiurnal Group plc Announces Chronocort MAA Submitted to the UK MHRADiurnal Group plc announced that an 'in flight' Market Authorisation Application (MAA) has been submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Chronocort® (modified-release hydrocortisone) as a treatment for adult and adolescent patients with the rare condition congenital adrenal hyperplasia (CAH) in Great Britain (England, Wales and Scotland). The MAA submission follows MHRA guidance following the end of the Brexit Transition Period and follows submission of an MAA to the European Medicines Agency (EMA) in December 2019, which was subsequently validated by the EMA in April 2020 and has continued along its planned review path with a marketing authorisation opinion for Chronocort® approval in the European Economic Area anticipated in first quarter of 2021. The submission for the MHRA is based on the same application submitted to the EMA in December 2019, including detailed analysis of data from the Company's Phase 3 study, the largest ever interventional clinical trial in CAH, an open-label safety extension study of Chronocort® and written formal Scientific Advice received in April 2019 confirming the clinical and regulatory pathway for Chronocort® as a treatment for patients with CAH. In parallel with the MHRA submission, Diurnal will seek confirmation of British Orphan Drug Status for Chronocort® in CAH, which requires the Company to demonstrate significant clinical benefit for the product compared to existing therapies. Should Chronocort® be approved, it will provide the potential for life-long treatment across Europe, with patients commencing treatment with Alkindi® (hydrocortisone granules in capsules for opening), the Company's approved paediatric product, transitioning to Chronocort® in adolescence and continuing with Chronocort® treatment into later life.
Is New 90 Day High Low • Dec 24New 90-day low: €0.48The company is down 41% from its price of €0.81 on 25 September 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.50 per share.
Is New 90 Day High Low • Nov 20New 90-day low: €0.54The company is down 29% from its price of €0.76 on 21 August 2020. The German market is up 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €0.48 per share.
공고 • Nov 12Diurnal Group plc to Report First Half, 2021 Results on Feb 23, 2021Diurnal Group plc announced that they will report first half, 2021 results on Feb 23, 2021
공고 • Oct 11+ 1 more updateDiurnal Group plc has completed a Follow-on Equity Offering in the amount of £8 million.Diurnal Group plc has completed a Follow-on Equity Offering in the amount of £8 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 13,333,333 Price\Range: £0.6 Transaction Features: Regulation S; Subsequent Direct Listing
Analyst Estimate Surprise Post Earnings • Oct 10Annual earnings released: Revenue beats expectationsAnnual revenue exceeded analyst estimates by 164% at UK£6.31m. Revenue is expected to shrink by 3.7% over the next year, compared to a 280% growth forecast for the Biotechs industry in Germany.
Reported Earnings • Oct 10Full year earnings released - €0.043 loss per shareOver the last 12 months the company has reported total losses of UK£4.07m, with losses narrowing by 67% from the prior year. Total revenue was UK£6.31m over the last 12 months, up by UK£5.26m from the prior year.
공고 • Oct 04Diurnal Group plc Announces Alkindi Sprinkle Approved by US FDADiurnal Group plc announced that the US Food and Drug Administration (FDA) has approved Alkindi® Sprinkle (hydrocortisone oral granules) as replacement therapy in paediatric patients with adrenocortical insufficiency (AI). This approval is based on a positive review of data from the Company's comprehensive development programme for Alkindi® Sprinkle, including a study to demonstrate bioequivalence with the US reference product, as well as a safety evaluation and tolerability extension study in Europe, which provides valuable long-term exposure data in support of market access in the US. Alkindi® Sprinkle is a patented, oral, immediate-release formulation of hydrocortisone granules in capsules designed for children. Alkindi® Sprinkle comes in dose strengths consistent with age-appropriate dosing in children. This therapeutic approach has the potential to help patients less than seventeen years of age suffering from diseases due to cortisol deficiency in the US. Diurnal has partnered with Eton Pharmaceuticals for the commercialisation activities of Alkindi® Sprinkle in the US, including pricing and reimbursement. Eton will initially use product from Diurnal's European Alkindi® supply chain, with an option to establish its own supply chain in the US in the future. As previously announced, under the terms of the licensing agreement, Diurnal will receive a $2.5 million cash milestone payment upon first commercial sale of Alkindi® Sprinkle in the US following grant of Orphan Drug Status. The Company will also receive a tiered royalty on sales ranging from low double-digits to high teens and is due tiered sales-based milestone payments of up to $45 million in aggregate subject to annual sales thresholds. These payments are in addition to the upfront payment of $5.0 million received by Diurnal upon signing the contract with Eton in March this year.
