The Law Offices of Frank R. Cruz reminds investors of the upcoming January 26, 2021 deadline to file a lead plaintiff motion in the case filed on behalf of investors who purchased Fortress Biotech, Inc. (“Fortress” or the “Company”) (NASDAQ: FBIO) securities between December 11, 2019 and October 9, 2020 inclusive (the “Class Period”).

If you are a shareholder who suffered a loss, click here to participate.

Fortress develops and commercializes pharmaceutical and biotechnology products. In December 2019, the Company's majority-controlled subsidiary, Avenue Therapeutics, Inc. ("Avenue"), 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.

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, thereby injuring investors.

The complaint filed alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors 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, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.

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If you purchased or otherwise acquired Fortress securities during the Class Period, you may move the Court no later than January 26, 2021 to request appointment as lead plaintiff in this putative class action lawsuit. To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to the pending class action lawsuit, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 1999 Avenue of the Stars, Suite 1100, Los Angeles, California 90067 at 310-914-5007, by email to info@frankcruzlaw.com, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.

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