Alkermes plc (ALKS -1.9%) is down in early trade, albeit on very light volume, on the heels of the news that an FDA advisory committee will meet on October 9 to review and discuss its marketing application for schizophrenia and bipolar disorder med ALKS 3821.
According to Mizuho Securities, the review heightens the risk of a hiccup in the path to approval since the agency has been approving applications without this tollgate.
The FDA’s action date is November 15.
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