Trevena is a biopharmaceutical company developing innovative therapies based on breakthrough science to benefit patients and healthcare providers confronting serious medical conditions. The Company is currently developing OLINVO (oliceridine) Injection, touted as a next generation IV analgesic for the management of moderate-to-severe acute pain in the hospital and similar settings and has been granted Breakthrough Therapy designation by the United States Food and Drug Administration (“FDA”). After the Company completed a Phase 2 trial of OLINVO, it issued a press release on May 2, 2016, stating that “[it] has reached general agreement with the FDA on key elements of the Phase 3 program to support a New Drug Application (NDA) for oliceridine[.]”
On October 9, 2018, it was revealed that the FDA informed the Company at a meeting with the agency in 2016, that the FDA “did not agree with the proposed dosing in the Phase 3 studies,” the proposed primary endpoint, or the “proposed non-inferiority (NI) margin for comparing morphine to oliceridine.” Following this news, shares of Trevena’s common stock fell more than 64% on October 9, 2018 to close at $1.07 per share.
According to the complaint, during the Class Period the defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and misleading statements and/or failed to disclose that: (i) the FDA had not agreed to key elements of the Company’s Phase 3 trial for oliceridine (TRV130); (ii) the FDA was unlikely to approve oliceridine (TRV130) based on the Company’s Phase 3 trial; and (iii) as a result, Trevena’s public statements were materially false and misleading at all relevant times. Case No. 2018-cv-04426-CMR (E.D. Pa.).
On August 28, 2020, the Court denied defendants’ motions to dismiss the amended complaint. A copy of the Court’s Opinion may be found at: 0 (law360.com).
In August 2021, the Court approved of a proposed settlement of the action for $8.5 million.