Business
Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2025 Financial Results and Business Updates
Initiation of confirmatory Phase 3 trial with roluperidone for negative symptoms of schizophrenia is planned for Q2 2026, with topline data anticipated in 2H
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Initiation of confirmatory Phase 3 trial with roluperidone for negative symptoms of schizophrenia is planned for Q2 2026, with topline data anticipated in 2H 2027BURLINGTON, Mass., March 11, 2026 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today provided business updates and reported financial results for the fourth quarter and year ended December 31, 2025. Business Updates Strategic Financing On October 23, 2025, Minerva received $80.0 million in gross proceeds from a private placement, before deducting fees and other expenses. The financing included initial upfront funding of $80.0 million and up to an additional $80.0 million if all Tranche A warrants are exercised, subject to the terms and conditions specified therein. Additional proceeds of $40.0 million may be received if all Tranche B warrants are exercised by cash payment upon the achievement of the primary endpoint of Minerva’s Phase 3 confirmatory trial of roluperidone in schizophrenia at the 12-week efficacy endpoint expected in 2H 2027. “Strengthened by the recent financing and our general alignment with the U.S. Food and Drug Administration (“FDA”) on trial design, we are working towards initiation of the confirmatory Phase 3 trial with roluperidone for the treatment of negative symptoms of schizophrenia in the second quarter,” said Dr. Remy Luthringer, Chairman and CEO of Minerva Neurosciences. “With the $80 million upfront proceeds and the exercise proceeds from the Tranche A warrants, we anticipate sufficient funds to complete the Phase 3 trial and resubmission of the New Drug Application (“NDA”) ahead of the launch of roluperidone in the United States, if approved.” Roluperidone - Potentially the First Treatment for Negative Symptoms of Schizophrenia Roluperidone is the only investigational therapy, to date, to demonstrate significant and clinically meaningful improvements on the primary negative symptoms of schizophrenia.Minerva has achieved general alignment with FDA on the confirmatory Phase 3 trial design.The Phase 3 trial remains on track to initiate in the second quarter of 2026, with a trial design similar to Minerva's two previous studies. The first phase of the trial has a primary efficacy endpoint to ev...