Read about all the latest news from Diurnal here.
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Positive Scientific Advice from European Medicines Agency for Chronocort®
Thursday, 11/Apr/2019European Medicines Agency confirms the current clinical and regulatory path for Chronocort®
Existing clinical data can be used to support a regulatory submission
Diurnal on track to submit Market Authorisation Application in Q4 2019 -
Diurnal signs marketing and distribution agreement for the commercialisation of Alkindi® in the Nordic region with Anthrop Pharma
Thursday, 28/Mar/2019Accelerates market access in valuable Nordic region to build on momentum in UK and Germany
First launch planned for Sweden in Q2 2019Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormo...
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Interim Results for the Six Months Ended 31 December 2018
Thursday, 28/Mar/2019Strong launches for Alkindi® in Germany and UK with further launches planned for 2019
Company on track for two major regulatory filings during 2019
Continued progress in emerging early-stage pipeline
Diurnal Group plc (AIM:... -
Update on Alkindi® US development
Wednesday, 20/Mar/2019US FDA confirms the current clinical and regulatory path for Alkindi: Diurnal on track to submit NDA in Q4 2019
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that following a po... -
Diurnal announces submission of Marketing Authorisation Application for Alkindi® and grant of second Alkindi® patent in Israel
Monday, 25/Feb/2019Significant opportunity to address unmet medical need, given the estimated higher prevalence of AI in Israel
Exemplifies Company’s approach of seeking approval for lead products outside core territoriesDiurnal Group plc (AIM: DNL), the specialty pharmaceuti...
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Diurnal announces grant of second US patent for Chronocort®
Thursday, 10/Jan/2019Method of treatment patent provides additional protection in key US market where Chronocort® has already received two Orphan Drug Designations
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine... -
Regulatory package for Chronocort® submitted for Scientific Advice in Europe
Tuesday, 11/Dec/2018Further analysis of data from European Chronocort® Phase III and safety extension study demonstrate significant benefits for patients sustained for at least 12 months
Analyst meeting to discuss the data to take place today
Subject to the o... -
Update on late-stage development pipeline
Wednesday, 17/Oct/2018Data from European Chronocort® Phase III safety extension study shows sustained benefits of treatment over at least 12 months
Company believes total Chronocort® development package warrants Scientific Advice meeting with EMA, with view to potentially submitting MAA in Q4 20...
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Scottish Medicines Consortium approves the use of Alkindi® as first-line treatment for paediatric adrenal insufficiency
Monday, 08/Oct/2018Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, is pleased to announce that the Scottish Medicines Consortium (SMC) has today approved the routine use of Alkindi® (hydrocortisone granules in capsule...
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Headline data for Chronocort® European Phase III clinical trial
Monday, 08/Oct/2018Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces headline data from the Chronocort® pivotal Phase III clinical trial in Europe for adults with congenital adrenal hyperplasia (CAH). Both re...
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First patients enrolled in US Chronocort® pivotal Phase III clinical trial for congenital adrenal hyperplasia
Friday, 05/Oct/2018Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the first two patients have been enrolled into the Chronocort® (modified release hydrocortisone) pivotal Phase III clinical trial (“RESTORE”) in t...
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Results for the year ended 30 June 2018
Thursday, 20/Sep/2018A transformational year as the Group reports first commercial revenues
Further key clinical and regulatory milestones expected in the next 12 months
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (...
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Update on Alkindi® in Germany
Wednesday, 15/Aug/2018Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, notes the publication of a clinical benefit dossier assessment of Alkindi® (hydrocortisone granules in capsules for opening) by the German Institute for Quality ...
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Diurnal announces the launch of Alkindi® for the treatment of paediatric adrenal insufficiency in Germany
Tuesday, 15/May/2018First Europe-wide licensed treatment specifically designed for younger children with adrenal insufficiency, an underserved population
First country to launch Alkindi®
First Diurnal product to be commercialised
Diurnal Group plc (AIM: DNL), the sp...
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Placing update
Tuesday, 20/Mar/2018This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014 ("MAR").
NEITHER THIS ANNOUNCEMENT NOR ANY PART OF IT CONSTITUTES AN OFFER TO SELL OR ISSUE OR THE SOLICITATION OF AN OFFER TO BUY, SU... -
Proposed Placing to raise up to £11 million, including Broker Option of up to £1 million and Notice of General Meeting
Wednesday, 14/Mar/2018Funds to be used to support the launch of Diurnal’s first approved product in Europe and the continued development of its product pipeline in the US and Europe
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormo...
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Appointment of global CRO to support the US clinical development of Chronocort®
Monday, 12/Mar/2018Phase III registration package expected to commence mid-2018
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today announces the appointment of the global contract research organisation (CRO), ...
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Interim Results for the Six Months Ended 31 December 2017
Monday, 12/Mar/2018European marketing authorisation for first product received post period end
Transformational year ahead with first country launch planned for Q2 2018
On track to becoming a world-leading specialty pharma company in endocrinologyDiurnal Grou...
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Diurnal announces grant of first patents for Alkindi® and Chronocort® in Japan
Thursday, 22/Feb/2018Pharmaceutical composition of matter patents in this key territory provides protection for Alkindi® and Chronocort® to 2032 and 2033, respectively
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases...
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Diurnal signs marketing and distribution agreement for the commercialisation of Alkindi® and Chronocort® in Australia and New Zealand with Emerge Health
Monday, 19/Feb/2018Further validation of Diurnal’s products and approach to global marketing and distribution in high value markets outside core Europe and US territories
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) dis...
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Diurnal receives European paediatric use marketing authorisation for Alkindi® as replacement therapy for paediatric adrenal insufficiency
Tuesday, 13/Feb/2018First licensed treatment in Europe specifically designed for use in children with adrenal insufficiency
Diurnal’s first product to receive marketing authorisation
Market launch anticipated in Q2 2018
Diurnal Group plc (AIM: DNL), the specialty ph...
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Completion of patient enrolment in European pivotal Phase III clinical study of Chronocort® for the treatment of Congenital Adrenal Hyperplasia
Monday, 12/Feb/2018Study scheduled to complete in Q3 2018; potential market authorisation in Europe in 2020
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has successfully completed patient enr...
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Diurnal reports positive results from food matrix compatibility study intended to form part of US registration package for Alkindi®
Tuesday, 09/Jan/2018Results show Alkindi® retains bioavailability in adults when administered with food
Dosage shown to be well tolerated
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces p...
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End of Year Business Update and Notice of Interim Results
Tuesday, 09/Jan/2018Imminent European approval of first product, Alkindi®, highlights Diurnal’s ability to realise its vision of becoming a world-leading endocrinology specialty pharma company
Clear registration pathway now established for Chronocort® in the US
Transformational...
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CHMP issues positive opinion for Alkindi® (Infacort®) for the treatment of paediatric adrenal insufficiency in Europe
Friday, 15/Dec/2017Positive opinion for approval includes paediatric patients up to 18 years of age
Alkindi® will be Diurnal’s first product to receive market authorisation; market launch anticipated in Q2 2018
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company tar...
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Pivotal Phase III data for Diurnal’s Infacort® published in Clinical Endocrinology
Friday, 15/Sep/2017Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that data from the pivotal Phase III trial for its lead product Infacort® are published in Clinical Endocrinology.
The paper titled, “Abso... -
Diurnal announces grant of first US patent for Chronocort®
Wednesday, 06/Sep/2017Diurnal announces grant of first US patent for Chronocort®
Composition of matter patent provides protection until 2033 in key US market where Chronocort® has already received Orphan Drug Designation
Diurnal Group plc (AIM: DNL), the specialty pharmaceuti...
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Results for the year ended 30 June 2017
Wednesday, 06/Sep/2017Results for the year ended 30 June 2017
First marketing authorisation expected H2 2017
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its audited results for ...
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First patient dosed in food matrix compatibility study intended to form part of US Phase III registration package for lead product, Infacort®
Thursday, 15/Jun/2017First patient dosed in food matrix compatibility study intended to form part of US Phase III registration package for lead product, Infacort®
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) disea...
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Diurnal announces grant of first US patent for lead product, Infacort®
Thursday, 18/May/2017Diurnal announces grant of first US patent for lead product, Infacort®
Composition of matter patent in this key territory provides protection to 2034
Company also announces receipt of Notice of Allowance for second US Infacort® patent application, co...
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Interim Results for the six months ended 31 December 2016
Monday, 20/Mar/2017On track to becoming a world leading specialty pharma company in endocrinology
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its results for the six months ended 31 December 2016.
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Diurnal appoints Clinigen to launch a European Patient Access programme for Infacort® and Chronocort®
Thursday, 16/Mar/2017Infrastructure and supply chain now in place to provide Infacort® and Chronocort® as unlicensed medicines to patients on a Named Patient basis
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocri...
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Diurnal signs marketing and distribution agreement for the commercialisation of Infacort® and Chronocort® in Israel
Thursday, 02/Mar/2017Diurnal signs marketing and distribution agreement for the commercialisation of Infacort® and Chronocort® with Israel's leading commercial group for niche healthcare products
Further validation of lead products in diseases of cortisol deficiency...
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Update on commercial pre-launch activities for Infacort®
Wednesday, 25/Jan/2017Appoints industry-leading outsourced commercial services providers to support potential product launch in late 2017
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces si... -
Diurnal announces the appointment of Richard Bungay as Chief Financial Officer
Thursday, 12/Jan/2017Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today announces the appointment of Richard Bungay as Chief Financial Officer (CFO), effective 16 January 2017. Richard succeeds Ian Ardill who has given notice o...
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Diurnal announces submission of European Paediatric Use Marketing Authorisation Application for Infacort® (hydrocortisone granules)
Tuesday, 20/Dec/2016European market authorisation anticipated in late 2017
First market authorisation submission by Diurnal
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces the sub... -
First patient dosed in testosterone replacement therapy for hypogonadism
Monday, 21/Nov/2016First patient dosed in testosterone replacement therapy for hypogonadism
Potential to be the first effective oral native testosterone treatment
Data expected in mid-2017
Represents third product into clinical... -
Diurnal announces full results from positive European Infacort® Phase III study
Wednesday, 12/Oct/2016As previously disclosed, primary endpoint met with high statistical significance
Results also show Infacort® achieved comparable cortisol levels in children with adrenal insufficiency to those of healthy childre...
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Results for the year ended 30 June 2016
Wednesday, 12/Oct/2016Significant progress towards becoming a revenue generating endocrinology specialty pharmaceutical company
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormon...
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Diurnal reports positive headline data from European Infacort® Phase III pivotal study
Monday, 11/Jul/2016Primary endpoint met, with Infacort® treatment achieving target cortisol levels in children aged less than six years
Major breakthrough in paediatric Adrenal Insufficiency, a condition of high unmet medical need with no currently licensed formulation for young ch... -
Diurnal announces Interim Results for the six months ended 31 December 2015
Wednesday, 30/Mar/2016Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its maiden results for the six months ended 31 December 2015.
Operational highlights- Initial Public Offerin...
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First patient dosed in Chronocort® pivotal clinical study for Congenital Adrenal Hyperplasia
Monday, 29/Feb/2016Two lead products in Phase III clinical development
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that the first patient has been dosed ...
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Admission to AIM and First Day of Dealings
Thursday, 24/Dec/2015Diurnal Group plc, the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that trading will commence today on AIM, a market of London Stock Exchange plc, at 8:00am under the ticker symbol (“DNL”) with ISIN GB00BDB6Q760.
The Compa...
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Publication of Admission Document, £30 million Fundraising and Proposed Admission to AIM
Monday, 21/Dec/2015Diurnal, the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that it has today published its Admission Document following a successful £30 million fundraising and has applied for the Admission of its entire issued and to be issued sh...
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FDA GRANT ORPHAN DRUG DESIGNATION TO DIURNAL LIMITED FOR CHRONOCORT®, A TREATMENT FOR ADRENAL INSUFFICIENCY
Tuesday, 15/Sep/2015Cardiff, UK - Diurnal Limited (“Diurnal” or “the Company”) today announced that it has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for Chronocort® in the treatment of Adrenal Insufficiency (“AI”). The designation provides seven years of market exclusivity ...
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Diurnal extends its Cooperative Research and Development Agreement with the National Institutes of Health
Tuesday, 04/Aug/2015Cardiff, UK – Diurnal Limited is pleased to announce an extension to its existing Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH), Maryland, US. The term of this CRADA will be extended until June 2021.
The extension will support a Phas...
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Diurnal Ltd appoints Peter Allen as Chairman
Wednesday, 01/Jul/2015Cardiff, UK – Diurnal Limited, the global specialty pharmaceutical company developing therapies for chronic endocrine diseases, is pleased to announce that Peter Allen has been appointed as Director and Chairman of the Board with immediate effect.
Peter has extensive experience in the h...
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FDA grants Orphan Drug Designation to Diurnal for Infacort®
Tuesday, 19/May/2015Cardiff, UK - Diurnal Limited (“Diurnal” or “the Company”) today announced that it has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for Infacort®, an oral hydrocortisone formulation for the treatment of paediatric Adrenal Insufficiency (“AI”). The designati...
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Diurnal Ltd announces new non-executive director
Friday, 24/Apr/2015Cardiff, UK – Diurnal Limited, a specialty pharmaceutical company dedicated to developing high-quality hormone therapeutics for patients with chronic endocrine diseases, has today announced the appointment of Alan Raymond as a non-executive director with immediate effect.
Dr Raymond... -
Diurnal announces Chief Financial Officer appointment
Wednesday, 22/Apr/2015Cardiff, UK – Diurnal Limited, a specialty pharmaceutical company committed to the development and commercialization of orphan drugs targeting chronic endocrine diseases, today announced the appointment of Mr Ian Ardill as Chief Financial Officer. Mr Ardill will also join the Board of Director...
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Diurnal enrols first patient onto Paediatric Phase 3 Study
Monday, 30/Mar/2015Cardiff, UK – Diurnal Limited, a specialty pharmaceutical company focused on developing treatments for rare and chronic endocrine conditions, is pleased to announce today that the first patient has been enrolled onto a Phase 3 trial of its paediatric product - Infacort® (immediate release hydr...
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FDA grant Orphan Drug Designation to Diurnal Limited for Chronocort®, a treatment for Congenital Adrenal Hyperplasia
Wednesday, 25/Mar/2015Cardiff, UK – Diurnal Limited today announced that it has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for its cortisol replacement product Chronocort®, an oral capsule drug candidate for the treatment of Congenital Adrenal Hyperplasia. The designation affo...
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Diurnal announces £6m funding round
Monday, 04/Aug/2014Cardiff, UK - Diurnal Limited (Diurnal), a spin-out company from the University of Sheffield, has today announced a fundraising of up to £6 million.
Diurnal's lead product Chronocort®, was recently the subject of a positive Phase 2 trial in the treatment of Congenital Adrenal Hyperplasi...
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Diurnal reports positive results from a Phase 2 Study in Congenital Adrenal Hyperplasia patients
Monday, 23/Jun/2014Diurnal Limited , a spin-out company from the University of Sheffield, today announced positive results from its Phase 2 CATCH (Chronocort® As Treatment for Congenital Adrenal Hyperplasia) clinical study in 16 adults with the rare disease Congenital Adrenal Hyperplasia (CAH).
The trial ...
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Successful completion of Infacort® 001 study
Monday, 09/Dec/2013Cardiff, UK - Diurnal Limited, a spin-out company from the University of Sheffield, today announced positive results from its Infacort 001 clinical study. The study in 16 healthy adult volunteers, forms part of the company's Infacort® development programme to develop a paediatric treatment for...
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Diurnal announces positive progress in Chronocort® Phase 2 trial
Tuesday, 03/Sep/2013Diurnal is pleased to announce that it has successfully completed the pharmacokinetic part of its Phase 2 CATCH (Chronocort® As Treatment for Congenital Adrenal Hyperplasia) clinical study.
Based in Cardiff, Diurnal is developing a novel approach to drug delivery that will help patients...
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First patient enrolled in CATCH Phase 2 trial
Sunday, 06/Jan/2013Diurnal is pleased to report that the first patient has been enrolled into the CATCH (Chronocort As Treatment for Congenital adrenal Hyperplasia) trial. The CATCH trial is a Phase 2 study in patients suffering from Congenital Adrenal Hyperplasia and is being run by the National Institute of H...
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Diurnal Appoints Martin Whitaker as CEO
Monday, 03/Sep/2012Diurnal today announces that Martin Whitaker, PhD has been appointed as its new Chief Executive Officer and Director of the Company.
Martin has previously held the position of General Manager within Diurnal. He brings to the role, as CEO of Diurnal, a strong track record of innovation,...
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Diurnal enters into a Cooperative Research and Development Agreement with the National Institute of Health
Monday, 16/Jul/2012Diurnal Limited, Cardiff, UK is pleased to announce that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Health (NIH), Maryland, US. The title of the CRADA is "Age-Appropriate Hydrocortisone Formulations for the Treatment of Adrenal ...
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Diurnal successfully completes Phase I trials and raises £1.2m to complete Phase II trials
Thursday, 21/Jun/2012Diurnal today announced that it has successfully completed its Phase I trial for its lead product, Chronocort® and raised £1.2M (€1.5M; USD $1.8M) to complete the Phase II trial by mid-2013.
Based in Cardiff, UK, Diurnal is developing a novel approach to drug delivery that will help pat...
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EU invests €4.2 million to boost paediatric hydrocortisone development
Wednesday, 30/May/2012Diurnal Limited is pleased to announce that it is a major partner in the collaborative research program - Treatment of Adrenal Insufficiency in Neonates (TAIN) - that for the first time will create a regulatory approved paediatric version of hydrocortisone specifically for neonates and infants...
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Diurnal raises £335K to initiate Phase 2 study planning
Thursday, 15/Mar/2012Diurnal, the physiological hormone replacement company, is pleased to announce that Diurnal has successfully raised £335K (USD$ 536K; Euro 400K) for its lead product, Chronocort®, to complete the final stage of its Phase I trial.
Based in Cardiff, Diurnal is developing a no...
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Diurnal announces successful completion of a clinical trial for Chronocort®
Tuesday, 31/Jan/2012Diurnal, the physiological hormone replacement company, is pleased to announce that its lead product, Chronocort®, has successfully completed a clinical trial in healthy volunteers. The trial involved the administration in humans of different formulations of Chronocort®
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Chronocort® Phase 1 Study Begins
Thursday, 18/Mar/2010Diurnal, the physiological hormone replacement company, today announced that it had completed enrolment of 30-healthy volunteers and begun its Phase 1 Chronocort® study at Simbec Research located in Merthyr Tydfil (Wales, UK).
Chronocort® is a modified release hydrocortison...
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Chronocort® Phase 1 Study Given Regulatory Approval
Wednesday, 24/Feb/2010Diurnal, the physiological hormone replacement company, today announced that it has received Medicines and Healthcare products Regulatory Agency (MHRA) and Ethics Approval to carry out an open label, randomised, single dose crossover study in healthy volunteers of its lead product Chronocort
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£770K investment in Diurnal
Saturday, 23/Jan/2010Diurnal, the physiological hormone replacement company, today announced that it has successfully completed a £770K ($USD 1.23M; Euro 850K) funding round that will enable its lead product, Chronocort®, to complete its Phase I trials and initiate its Phase 2 trials.
Based in Cardiff, Di...
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£600k Investment in Diurnal
Sunday, 06/Dec/2009Diurnal, the physiological hormone replacement company, completed a £600,000 (USD $1M; Euro €650K) investment round led by Fusion IP PLC, the university commercialisation company which turns university research into business, and Finance Wales. Both Fusion IP and Finance Wales invested £300,00...
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Diurnal Secures £450K Investment
Wednesday, 01/Apr/2009Diurnal, the physiological hormone replacement company, announced today that it has secured more than £250,000 (USD $350K; Euro €280K) in venture capital investment from Finance Wales, Fusion IP PLC and the Viking Fund.
Diurnal received the investment and an additional £200,000 (USD $28...
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Diurnal Secures Complete Data Package for Chronocort® from Phoqus Pharmaceuticals PLC
Monday, 01/Dec/2008Diurnal Limited has announced today that it has secured the return of the clinical, commercial and intellectual property data package from Phoqus Pharmaceuticals PLC.
Diurnal was founded in 2004 as a spin-out from the University of Sheffield (Sheffield, UK) based on t...