03:05 , Jun 30, 2018 |  BioCentury  |  Finance

Hidden in the rough

Judicious stock picking was especially important in the second quarter, as 57% of global biotech stocks saw their equity values decline. Volatility continued to roil global markets during the period and additional uncertainty looms with the...
16:32 , Apr 20, 2018 |  BC Week In Review  |  Clinical News

FDA accepts NDA for Alkermes' depression candidate, reversing refusal

FDA accepted for review an NDA for ALKS 5461 from Alkermes plc (NASDAQ:ALKS) as an adjunctive treatment of major depressive disorder, reversing the agency’s decision to refuse to file the application. The decision will not...
13:53 , Apr 16, 2018 |  BC Extra  |  Company News

FDA reverses Alkermes refuse-to-file decision

FDA has accepted for review an NDA for ALKS 5461 from Alkermes plc (NASDAQ:ALKS) as an adjunctive treatment of major depressive disorder, reversing the agency’s decision to refuse to file the application. The decision will...
20:52 , Apr 6, 2018 |  BC Week In Review  |  Clinical News

FDA refuses to file Alkermes' NDA for depression candidate

Alkermes plc (NASDAQ:ALKS) sank $12.73 (22%) to $45.23 on April 2 after it said FDA issued a refusal-to-file letter for its NDA for ALKS 5461 as an adjunctive treatment for major depressive disorder (MDD) in...
14:29 , Apr 2, 2018 |  BC Extra  |  Company News

FDA declines to review Alkermes' antidepressant

Alkermes plc (NASDAQ:ALKS) sank $12.73 (22%) to $45.23 on Monday after it said FDA issued a refusal-to-file letter for its NDA for ALKS 5461 as an adjunctive treatment for major depressive disorder (MDD) in patients...
23:10 , Oct 6, 2017 |  BioCentury  |  Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...
19:48 , Sep 8, 2017 |  BC Week In Review  |  Clinical News

Alkermes begins rolling NDA submission for ALKS 5461 in MDD

Alkermes plc (NASDAQ:ALKS) began submission of a rolling NDA to FDA for ALKS 5461 as adjunctive treatment of major depressive disorder (MDD). The company plans to complete the submission by year end. ALKS 5461 is a...
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
21:27 , Jun 16, 2017 |  BC Week In Review  |  Clinical News

Alkermes begins Phase IIIb of ALK 5461 in MDD

Alkermes plc (NASDAQ:ALKS) began the double-blind, placebo-controlled, international Phase IIIb Study 217 to evaluate once-daily oral ALKS 5461 for 11 weeks as adjunctive treatment in about 325 patients with major depressive disorder (MDD). The trial’s primary...
19:53 , Feb 17, 2017 |  BC Week In Review  |  Clinical News

ALKS 5461 regulatory update

Alkermes plans to submit an NDA to FDA next half for ALKS 5461 as adjunctive treatment of major depressive disorder (MDD). Last October, the higher of 2 doses of ALKS 5461 met the primary endpoint...