According to the Complaint, Fortress Biotech, Inc. develops and commercializes pharmaceutical and biotechnology products. In December 2019, the Company's majority-controlled subsidiary, Avenue Therapeutics, Inc., which Fortress founded in 2015, submitted a New Drug Application for its intravenous Tramadol product to the U.S. Food and Drug Administration 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, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) IV Tramadol was not safe for the intended patient population; (ii) as a result, it was foreseeable that the FDA would not approve the NDA for IV Tramadol; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times.