Shares of biopharmaceutical company Alkermes PLC (NASDAQ:ALKS) soared in pre-market trade after the US Food and Drug Administration accepted the firm's new drug application for its treatment of clinical depression.
The drug ALKS 5461 is a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard anti-depressant therapies.
The stock gained 17% to US$49.80.
The company's shares plunged 22% on April 2 when investors learned the FDA had issued a "refusal to file" letter for ALKS 5461 on March 30.
Terence Flynn, Goldman Sachs' lead analyst for the large cap US biotechnology sector, saw the FDA review as a positive, but kept a Neutral rating on the stock.
The FDA will most likely convene an advisory panel in Q4 to review the filing, Flynn told clients in a research note. He did not rule out the possibility of the FDA requesting an additional trial from Alkermes.
-- Updates two include Goldman Sachs rating and comments.