LOS ANGELES–()–Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, announces that a class action lawsuit has been filed on behalf of investors who purchased or otherwise acquired Fortress Biotech, Inc. (“Fortress” or the “Company”) (NASDAQ: FBIO) securities between December 11, 2019 and October 9, 2020 inclusive (the “Class Period”). Fortress investors have until January 26, 2021 to file a lead plaintiff motion.

If you suffered a loss on your Fortress investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws, you can submit your contact information at https://www.glancylaw.com/cases/fortress-biotech-inc/. You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at shareholders@glancylaw.com to learn more about your rights.

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 ask the Court to appoint you as lead plaintiff. To be a member of the Class 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. If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Charles Linehan, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to shareholders@glancylaw.com, or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.



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