Alkermes Comments On FDA Panel May Pressure Shares, Says Mizuho

Mizuho analyst Vamil Divan believes details in Alkermes' (ALKS) announcement this morning that the FDA will hold an advisory committee meeting on October 9 to discuss ALKS 3831, a treatment of schizophrenia and bipolar disorder, may put pressure on the shares.

The analyst says investors already knew a meeting was coming ahead of the November 15 action date and that it would focus on the clinical meaningfulness of the ALKS 3831 data. Importantly, though, Alkermes this morning disclosed that the meeting will discuss "certain potential clinical risks related to the interaction of ALKS 3831...and opioids in the intended patient populations," Divan tells investors in a research note.

With most investors assuming an on-time approval of ALKS 3831, today's disclosure "raises some questions on that," and may lead to some pressure on the stock, says the analyst. Divan has a Neutral rating on Alkermes with a $19 price target.

The stock is down 2% to $17.78 in early trading.