Shares of Alkermes Plc ALKS are trading up more than 40 percent in Thursday’s after-hours session, after the company announced positive topline results from its late-stage clinical study of ALKS 5461 for the treatment of depression.
According to data out of FORWARD-5, the company’s third phase 3 efficacy study, ALKS 5461 considerably reduced the symptoms seen in patients with major depression disorder, compared to a placebo.
Based on these results, the company said it plans to “move forward rapidly to meet with the FDA to determine the appropriate next steps toward a regulatory submission for ALKS 5461.”
“ALKS 5461 is being developed as an add-on treatment for patients with depression not controlled by currently approved drugs. The pill had been touted by Alkermes as a potential blockbuster and an important growth driver based on promising results from a mid-stage study,” TheStreet's Adam Feuerstein explained.
Shares traded recently at $61.28, up 41 percent.
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