23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
13:03 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

EC approves Diurnal's Alkindi

Diurnal Group plc (LSE:DNL) said the European Commission approved Alkindi (Infacort) as a replacement therapy to treat adrenal insufficiency in individuals less than 18 years old. Diurnal plans to launch Alkindi in 2Q18, but told...
21:15 , Feb 13, 2018 |  BC Extra  |  Company News

EC approves Diurnal's Alkindi

Diurnal Group plc (LSE:DNL) said the European Commission approved Alkindi (Infacort) as a replacement therapy to treat adrenal insufficiency in individuals less than 18 years old. Diurnal plans to launch Alkindi in 2Q18, but told...
15:04 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

CHMP recommends Diurnal's Alkindi for pediatric adrenal insufficiency

EMA's CHMP recommended approval of Alkindi (Infacort) from Diurnal Ltd. (Cardiff, U.K.) as replacement therapy for pediatric adrenal insufficiency. The company expects a final decision in February and anticipates a launch in 2Q18. The product is...
21:50 , Apr 20, 2017 |  BC Week In Review  |  Company News

Diurnal, Clinigen sales and marketing update

Clinigen launched a patient access program in Europe to provide Diurnal’s cortisol deficiency candidates Infacort and Chronocort on a named-patient basis to patients who have no other treatment options. Infacort is under EMA review to treat...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Clinical News

Infacort: Extension study started

Diurnal began an open-label extension study in up to 24 patients ages <6 who completed treatment in a German Phase III trial of 0.5, 1, 2 and 5 mg oral Infacort. The trial, which met...
07:00 , Oct 24, 2016 |  BC Week In Review  |  Clinical News

Infacort: Phase III final data

Final data from an open-label, German Phase III trial in 24 patients ages <6 with adrenal insufficiency due to congenital adrenal hyperplasia, primary adrenal failure or hypopituitarism showed that a single dose of oral Infacort...
07:00 , Aug 1, 2016 |  BC Week In Review  |  Clinical News

Infacort: Phase III data

Top-line data from an open-label, German Phase III trial in 24 patients ages <6 with adrenal insufficiency due to congenital adrenal hyperplasia, primary adrenal failure or hypopituitarism showed that a single dose of oral Infacort...