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Alkermes stock soars after FDA accepts its clinical depression drug for review

Goldman Sachs saw the FDA review as a positive, but kept a neutral rating on the stock
A medical researcher
The bio-pharma stock had plunged after the FDA refusal, but it bounced back on Monday

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.

READ: Alkermes shares tumble 20% as FDA says it needs more trial data for depression drug

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.


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