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Hardman Research: Alkindi®: On route to Europe

19 Dec 2017 12:53

RNS Number : 8067Z
Diurnal Group PLC
19 December 2017
 

Hardman Research: Alkindi®: On route to Europe

Alkindi®: On route to Europe: Diurnal is a clinical stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead candidates are targeted at rare diseases with unmet medical need, with the aim of building a long-term 'Adrenal Franchise'. Following successful completion of a Phase III trial, Alkindi® (previously known as Infacort®) has received a positive opinion from the CHMP, recommending the granting of market authorisation for replacement therapy in adrenal insufficiency for children from birth up to 18 years of age. The European Commission is expected to grant market approval in February, allowing first sales in 2Q 2018.

 

Please click here for the full report:

http://hardmanandco.com/docs/default-source/company-docs/diurnal-ltd-documents/19-12-17-diurnal.pdf

 

To contact us:

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London

EC2M 1NH

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Dr Martin Hall mh@hardmanandco.com

Dr Dorothea Hill dmh@hardmanandco.com

Dr Gregoire Pave gp@hardmanabdco.com

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About Hardman & Co: For the past 20 years Hardman has been producing specialist research designed to improve investors' understanding of companies, sectors, industries and investment securities. Our analysts are highly experienced in their sectors, and have often been highly rated by professional investors for their knowledge. Our focus is to raise companies' profiles across the UK and abroad with outstanding research, investor engagement programmes and advisory services. Some of our notes have been commissioned by the company which is the subject of the note; this is clearly stated in the disclaimer where this is the case.

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NRAFFUFEUFWSELE
Date   Source Headline
30th Apr 20193:40 pmRNSHolding(s) in Company
30th Apr 20192:43 pmRNSHolding(s) in Company
26th Apr 20195:52 pmRNSDirector Dealings and Issue of Equity
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25th Apr 20197:15 amEQSHardman & Co Research: Diurnal Group (DNL): Clarity for Chronocort regulatory pathway
24th Apr 20197:00 amRNSGrant of Orphan Drug Designation in Australia
11th Apr 20197:00 amRNSPositive Scientific Advice from EMA for Chronocort
28th Mar 20197:00 amRNSDiurnal signs marketing and distribution agreement
28th Mar 20197:00 amRNSInterim Results
20th Mar 20197:00 amRNSUpdate on Alkindi US development
25th Feb 20197:00 amRNSSubmission of MAA for Alkindi and Second Patent
11th Feb 201911:00 amRNSNotice of Interim Results
17th Jan 20197:00 amRNSDirector Dealings
16th Jan 20197:15 amEQSHardman & Co Research: Diurnal Group (DNL): Chronocort - seeking regulatory advice
10th Jan 201912:18 pmRNSStatement regarding Price Movement
10th Jan 20197:00 amRNSGrant of second US patent for Chronocort
24th Dec 20187:00 amRNSDirector Dealings and Issue of Equity
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11th Dec 20187:00 amRNSRegulatory package for Scientific Advice in Europe
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14th Nov 201811:38 amRNSResults of Annual General Meeting
14th Nov 201810:16 amRNSIssue of Equity and Exercise of Options
18th Oct 20187:15 amEQSHardman & Co Research: Diurnal Group (DNL): Unexpected Phase III trial outcome
17th Oct 20187:00 amRNSUpdate on late-stage development pipeline
8th Oct 20184:00 pmRNSPosting of Annual Report and AGM Notice
8th Oct 20182:45 pmRNSSMC Approves The Use of Alkindi
8th Oct 20187:00 amRNSHeadline Data for Chronocort European Phase III
5th Oct 20187:00 amRNSFirst patients enrolled in US Chronocort Phase III
20th Sep 20187:00 amRNSResults for the year ended 30 June 2018
15th Aug 201811:11 amRNSUpdate on Alkindi® in Germany
10th Jul 20181:36 pmRNSDirector/PDMR Shareholding
21st Jun 20187:00 amRNSNotice of Results
18th Jun 20184:54 pmRNSDirector/PDMR Shareholding
18th May 20183:33 pmRNSDirector Dealings
18th May 20181:11 pmRNSAppointment of NOMAD and Joint Broker
15th May 20188:13 amRNSLaunch of Alkindi for paediatric AI in Germany
11th May 20182:41 pmRNSDirector Declaration
17th Apr 20183:58 pmRNSHolding(s) in Company
5th Apr 20182:08 pmRNSDirector/PDMR Shareholding
5th Apr 20188:01 amRNSDirector/PDMR Shareholding
3rd Apr 20182:39 pmRNSResult of GM and Completion of £10.5m Placing
21st Mar 20187:15 amRNSHardman & Co: New capital funds commercial plans
20th Mar 20185:20 pmRNSPlacing Update
14th Mar 20188:47 amRNSProposed Placing
12th Mar 20187:00 amRNSAppointment of CRO to support US Chronocort trials
12th Mar 20187:00 amRNSHalf-year Report
22nd Feb 20187:00 amRNSDiurnal announces grant of first patents in Japan
19th Feb 20187:00 amRNSCommercialisation agreement in Australia and NZ
13th Feb 20187:00 amRNSEuropean marketing authorisation for Alkindi®
12th Feb 20187:00 amRNSCompletion of patient enrolment in EU Phase III

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