San Diego, CA -- (SBWIRE) -- 12/14/2020 -- An investor, who purchased NASDAQ: FBIO shares, filed a lawsuit against Fortress Biotech, Inc over alleged violations of Federal Securities Laws.

Investors who purchased shares of Fortress Biotech, Inc. (NASDAQ: FBIO) have certain options and for certain investors are short and strict deadlines running. Deadline: January 26, 2021. NASDAQ: FBIO investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

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."

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.

Those who purchased shares of Fortress Biotech, Inc. (NASDAQ: FBIO) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.