According to the Complaint, Trevena, Inc. ("Trevena" or the Company) is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. Using its proprietary product platform, Trevena has identified four biased ligand product candidates, including oliceridine (TRV130) to treat moderate to severe acute pain intravenously.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's interactions with the FDA. Specifically, Trevena misled its shareholders to believe that its April 28, 2016 End-of-Phase 2 Meeting with the United States Food and Drug Administration ("FDA") was far more successful than it actually was. The Company did so by issuing a press release entitled "Trevena Announces Successful End-of-Phase 2 Meeting with FDA and Outlines Phase 3 Program for Oliceridine," on May 2, 2016, in which it announced that it had "reached general agreement" with the FDA on key elements of its Phase 3 program for oliceridine (TRV130) and was "very pleased" with the outcome of its discussions with the FDA. In reality, the FDA disagreed with Trevena on several key factors relating to whether oliceridine would ultimately be approved for commercial distribution. Trevena's filings therefore concealed the true risks faced by the Company in gaining ultimate FDA approval.