Alkermes shares take another hit as the FDA shakes its head — again — on a weak case for '5461
The FDA really, really doesn’t like Alkermes’ NDA for its highly touted depression drug ALKS-5461.
Gunned down by agency experts in a lopsided adcomm vote, hammered by regulators for fashioning its own questionable endpoints — against their advice — and generally trashed for running one of the worst late-stage programs on record, Alkermes $ALKS today put out word after the market closed on Friday that the drug was rejected by the FDA.
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