Posted by Michael Wonder on 22 Oct 2016
A biotech's depression drug returns from dead, setting up test for FDA
20 October 2016 - In January, Alkermes, a Waltham, Mass.-based biotechnology firm, announced that its experimental antidepressant, code-named ALKS 5461, had failed in two different clinical trials.
Shares in the company fell from $60 to $33. Today, Alkermes announced that a third study of the drug had succeeded, leading shares to jump 43% in after-hours trading to about $60 — essentially erasing the specter of failure.
That stock pop is obviously too much. It’s good news that the drug proved effective in another study. But the big question is whether the Food and Drug Administration will be willing to approve ALKS 5461 based on this study, or whether it will demand that Alkermes conduct another clinical trial that has not yet begun yet. Alkermes will meet with the FDA to discuss its options.
