Diurnal submits application for 'Alkindi Sprinkle' to US FDA
2nd Dec 2019 13:19
(Sharecast News) - Specialty pharmaceutical company Diurnal Group has submitted a 'New Drug Application' (NDA) to the US Food and Drug Administration (FDA), for the regulatory approval of 'Alkindi Sprinkle', or hydrocortisone granules in capsules for opening, as a replacement therapy of adrenal insufficiency in infants, children and adolescents in the US, it announced on Monday.
Read moreDiurnal Group launches placing and open offer to fund drug development
28th May 2019 13:32
(Sharecast News) - Specialty pharmaceutical company Diurnal Group announced a conditional placing of new ordinary shares in the company and the launch of an open offer on Tuesday, in order to raise funds to progress the development and commercialisation of its products.
Read moreDiurnal gets orphan drug designation for Alkindi in Australia
24th Apr 2019 15:50
(Sharecast News) - Specialty pharmaceutical company Diurnal Group announced on Wednesday that its 'Alkindi' product - hydrocortisone granules in capsules for opening - had been granted orphan drug designation in Australia by the Therapeutic Goods Administration, for the indication 'replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents from birth to 18 years old'.
Read moreDiurnal soars after securing Nordic distribution deal
28th Mar 2019 08:35
(Sharecast News) - Diurnal's shares leapt on Thursday despite a widened interim loss as the company landed a marketing and distribution deal for its Alkindi treatment in Scandinavia.
Read moreDiurnal Group upbeat following FDA meeting over 'Alkindi'
20th Mar 2019 10:33
(Sharecast News) - Specialty pharmaceutical company Diurnal Group announced on Wednesday that, following a "positive" meeting with the US Food and Drug Administration (FDA), it intended to submit a new drug application (NDA) for 'Alkindi' (hydrocortisone granules in capsules for opening) in the fourth quarter of 2019 as previously planned, with final acceptance of the filing by the FDA expected in 2020.
Read moreDiurnal expecting Israel launch of 'Alkindi' next year
25th Feb 2019 10:39
(Sharecast News) - Specialty pharmaceutical company Diurnal Group announced on Monday that its marketing and distribution partner, Medison Pharma has successfully submitted a market authorisation application (MAA) for its 'Alkindi' (hydrocortisone granules in capsules for opening) product to the Ministry of Health in Israel.
Read moreDiurnal awarded US patent for Chronocort product
10th Jan 2019 11:26
(Sharecast News) - Specialty pharmaceutical company Diurnal Group announced on Thursday that the US Patent and Trademark Office (USPTO) has granted a second US patent for its 'Chronocort' modified release hydrocortisone product.
Read moreDiurnal halts US development of Chronocort after European trials come up short
17th Oct 2018 12:10
(Sharecast News) - Speciality pharmaceutical company Diurnal has put all development activities for its modified release hydrocortisone product on hold after it failed to meet its primary endpoint in a recent phase-three European trial.
Read moreDiurnal's endocrine drug does not meet trial objective
8th Oct 2018 09:29
(Sharecast News) - Clinical trials of Diurnal Group's Chronocort drug failed to meet the primary objective of proving superior to conventional therapy in endocrine control over a 24-hour period.
Read moreDiurnal kicks off adrenal condition trial with first patients
5th Oct 2018 09:20
(Sharecast News) - Specialist pharmaceutical company Diurnal said it had enrolled the first two patients in its US-based Chronocort phase III trial for adults with congenital adrenal hyperplasia (CAH).
Read moreDirector dealings: Diurnal trio dip in after EMA submission in December
16th Jan 2017 15:08
(ShareCast News) - A trio of Diurnal Group directors bought shares in the hormone disease specialist, which remain little higher than the low reached late last year. Chairman Peter Allen bought 40,000 shares at 105p and non-executive directors Sam Williams and John Goddard bought 9,248 each at a pri
Read moreDiurnal and IP Group eye 2017 launch for childhood hormonal treatment
11th Jul 2016 08:00
(ShareCast News) - Diurnal Group, 45%-owned by university spin-out specialist IP Group, has produced positive clinical trial results for its treatment for a rare hormonal disease in young children. A European Phase III study for AIM-quoted Diurnal's Infacort treatment for paediatric Adrenal Insuffic
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