Sign up Australia
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

1528305384_Untitled-design-(3).jpg
June 07 2018
Ventripoint received key FDA approval to sell the device with the four-chamber heart analysis last month
picture of addict
November 16 2017
To build the UK's first £1bn, self-sustainable biotech is the aim for chief executive Clive Dix
1511901712_biotech_517925923.jpg
November 29 2017
The company has developed a "unique and superior pressure" cycling technology (PCT), says Zacks.

No investment advice

The information on this Site is of a general nature only. It does not take your specific needs or circumstances into consideration, so you should look at your own financial position, objectives and requirements and seek financial advice before making any financial decisions. You acknowledge and understand that neither the Company, its related bodies corporate, the information providers or their affiliates will advise you personally about the nature, potential value or suitability of any particular security, portfolio of securities, transaction, investment strategy, or other matter. You should read our FSG and any other relevant disclosure documents and if necessary seek persona advice prior to making any investment decision.

You understand and agree that no Content (as defined below) published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable or advisable for any specific person.

You understand that in certain circumstances the Company, its related bodies corporate, the information providers or their affiliates may have received, or be entitled to receive, financial or other consideration in connection with promoting, and providing information about, certain entities on the Site and in communications otherwise provided to you.

You understand that price and other data is supplied by sources believed to be reliable, that the calculations herein are made using such data, and that neither such data nor such calculations are guaranteed by these sources, the Company, the information providers or any other person or entity, and may not be complete or accurate. From time to time, reference may be made in our marketing materials to prior articles and opinions we have published. These references may be selective, may reference only a portion of an article or recommendation, and are likely not to be current. As markets change continuously, previously published information and data may not be current and should not be relied upon.

Before you act on any general advice we provide, please consider whether it is appropriate for your personal circumstances.

© Proactive Investors 2018

Proactive Investors Australia PTY LTD ACN:132787654 ABN:19132787654.

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