Alkermes soars as MMD candidate hits Phase III goals

Ireland-headquartered Alkermes’ (Nasdaq: ALKS) shares jumped 47% to $64 in after hours trading from a Nasdaq close at $43.51 on Thursday, after the company announced positive top-line results from FORWARD-5, the third Phase III efficacy study to read out from the FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies.

The study met its pre-specified primary endpoint showing treatment with ALKS 5461 significantly reduced symptoms of depression in patients with MDD compared to placebo. ALKS 5461 was generally well tolerated. The most common adverse events observed for ALKS 5461 were nausea, dizziness and fatigue.

To meet with FDA on regulatory filing strategy