November 27, 2020 - An investor in shares of Fortress Biotech, Inc. (NASDAQ: FBIO) filed a lawsuit in the U.S. District Court for the Eastern District of New York over alleged violations of Federal Securities Laws by Fortress Biotech, Inc. in connection with certain allegedly false and misleading statements made between December 11, 2019 and October 9, 2020.

New York based Fortress Biotech, Inc. develops and commercializes pharmaceutical and biotechnology products. Fortress Biotech, Inc. reported that its annual Total Revenue rose from $26.88 million in 2018 to $36.62 million in 2019, and that its normalized Loss declined from $71.37 million in 2018 to $58.4 million in 2019. In December 2019, the Company's majority-controlled subsidiary, Avenue Therapeutics, Inc. ( Avenue ), which Fortress Biotech, Inc. 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.

On October 12, 2020, Avenue Therapeutics, Inc disclosed receipt of a Complete Response Letter ( CRL ) from the FDA regarding the NDA for its IV Tramadol product. Specifically, the FDA advised Avenue Therapeutics, Inc 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. Shares of Fortress Biotech, Inc. (NASDAQ: FBIO) declined from $4.78 per share in September 2020 to as low as $2.12 per share in November 2020.

According to the complaint the plaintiff alleges on behalf of purchasers of Fortress Biotech, Inc. (NASDAQ: FBIO) common shares between December 11, 2019 and October 9, 2020, that the defendants violated Federal Securities Laws.

More specifically, the plaintiff claims that between December 11, 2019 and October 9, 2020, the Defendants made false and/or misleading statements and/or failed to disclose that IV Tramadol was not safe for the intended patient population, that as a result, it was foreseeable that the FDA would not approve the NDA for IV Tramadol, and that as a result, the Company's public statements were materially false and misleading at all relevant times.