Biotech Stocks Facing FDA Decision In November


A panel of outside experts convened by the FDA is scheduled to review Alkermes plc’s (ALKS) New Drug Application for ALKS 5461 on November 1, 2018.

Proposed for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies, ALKS 5461 is a once-daily, oral investigational fixed-dose combination of buprenorphine and samidorphan.

If approved, the Company expects ALKS 5461, which has a novel mechanism of action, to be a "blockbuster".

The FDA’s final decision on ALKS 5461 is expected on January 31, 2019. The regulatory agency usually follows the decisions of its panels, although it is not mandatory.

ALKS closed Friday’s trading at $41.38, down 0.70%.