Sign up United Kingdom
Proactive Investors - Run By Investors For Investors

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.


View full ALKS profile View Profile

Alkermes Timeline

Related Articles

picture of addict
November 15 2017
To build the UK's first £1bn, self-sustainable biotech is the aim for chief executive Clive Dix
June 06 2018
Ventripoint received key FDA approval to sell the device with the four-chamber heart analysis last month
November 29 2017
The company has developed a "unique and superior pressure" cycling technology (PCT), says Zacks.

© Proactive Investors 2018

Proactive Investors Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use