NEW YORK, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of the securities of Fortress Biotech, Inc. (NASDAQ: FBIO) between December 11, 2019 to October 9, 2020, inclusive (the "Class Period"). The lawsuit seeks to recover damages for Fortress investors under the federal securities laws.

To join the Fortress class action, go to http://www.rosenlegal.com/cases-register-1997.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

Fortress develops and commercializes pharmaceutical and biotechnology products. In December 2019, the Company's majority-controlled subsidiary, Avenue Therapeutics, Inc. ("Avenue"), which Fortress founded in 2015, submitted a New Drug Application ("NDA") for its intravenous ("IV") Tramadol product to the U.S. Food and Drug Administration ("FDA") for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.

The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (1) IV Tramadol was not safe for the intended patient population; (2) as a result, it was foreseeable that the FDA would not approve the NDA for IV Tramadol; and (3) as a result, the Company's public statements were materially false and misleading at all relevant times.

On October 12, 2020, Avenue disclosed receipt of a Complete Response Letter ("CRL") from the FDA regarding the NDA for its IV Tramadol product. Specifically, the FDA advised Avenue that "it cannot approve the application in its present form" because "IV tramadol, intended to treat patients in acute pain who require an opioid, is not safe for the intended patient population." Specifically, the CRL stated: "[I]f a patient requires an analgesic between the first dose of IV tramadol and the onset of analgesia, a rescue analgesic would be needed. The likely choice would be another opioid, which would result in opioid 'stacking' and increase the likelihood of opioid-related adverse effects."

On this news, Fortress's stock price fell $1.00 per share, or 23.98%, to close at $3.17 per share on October 12, 2020.

A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than January 26, 2021. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to join the litigation, go to http://www.rosenlegal.com/cases-register-1997.html or to discuss your rights or interests regarding this class action, please contact Phillip Kim, Esq. of Rosen Law Firm toll free at 866-767-3653 or via e-mail at pkim@rosenlegal.com or cases@rosenlegal.com.

NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY RETAIN COUNSEL OF YOUR CHOICE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER AND DO NOTHING AT THIS POINT. AN INVESTOR’S ABILITY TO SHARE IN ANY POTENTIAL FUTURE RECOVERY IS NOT DEPENDENT UPON SERVING AS LEAD PLAINTIFF.

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Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 3 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm’s attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors. Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:

        Laurence Rosen, Esq.
        Phillip Kim, Esq.
        The Rosen Law Firm, P.A.
        275 Madison Avenue, 40th Floor
        New York, NY 10016
        Tel: (212) 686-1060
        Toll Free: (866) 767-3653
        Fax: (212) 202-3827
        lrosen@rosenlegal.com
        pkim@rosenlegal.com
        cases@rosenlegal.com
        www.rosenlegal.com