BioCentury
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Alkermes rises after MDD therapy passes Phase III test

October 20, 2016 7:00 AM UTC

Alkermes plc (NASDAQ:ALKS) gained $19.47 (45%) to $62.98 in early after-hours trading Thursday after it said the higher of two doses of ALKS 5461 met the primary endpoint of the FORWARD-5 trial as an adjunctive therapy for major depressive disorder in patients who do not respond adequately to standard antidepressants. Alkermes hopes to meet with FDA to discuss a regulatory submission strategy for the compound, which combines buprenorphine with samidorphan (ALKS 33), a mu opioid receptor ( OPRM1; MOR) antagonist.

In two previous Phase III MDD studies, ALKS 5461 missed the primary endpoint of improving Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline vs. placebo. Alkermes shares sank 44% on Jan. 21 after the company disclosed those results. They had closed at $60.42 on Jan. 20 (see BioCentury Extra, Jan. 21). ...