Minerva reports Q3 2026 results, confirms roluperidone Phase 3 timelines

Minerva Neurosciences reported financial and business updates for the quarter ended September 30, 2026 on November 6, 2026. The company's ongoing global Phase 3 trial of roluperidone for negative symptoms of schizophrenia, known as the C19 Study, is designed to enroll 380 patients at approximately 40 clinical sites worldwide, including sites in the United States and multiple European countries.¹ The design follows discussions with the FDA and builds on the company's earlier Phase 2b and Phase 3 trials, C03 and C07.¹

Phase A of the trial is testing 64 mg of roluperidone against placebo to confirm an effect on primary negative symptoms at 12 weeks, with topline data expected in the second half of 2027.¹ Phase B will follow, assessing longer-term relapse of positive symptoms versus commonly prescribed antipsychotics over an additional 52 weeks, with topline data expected in the second half of 2028.¹ CEO Remy Luthringer said the company remains focused on execution and on track for topline efficacy data in the second half of 2027.¹

Separately, Luthringer and Chief Medical Officer Michael Davidson published a paper titled "Development of non-dopamine active drugs for negative symptoms" in Schizophrenia Research, which argues that basic science needs to look past dopaminergic mechanisms and that clinical trial methodology for negative symptoms needs improvement.¹

On finances, cash, cash equivalents, marketable securities and restricted cash totaled about $77.0 million as of September 30, 2026, down from $82.4 million at the end of 2025.¹ The company posted GAAP net income of $100.7 million for the quarter, driven by a $109.6 million non-cash gain on the warrant liability tied to its October 2025 private placement; excluding that gain, adjusted net loss was $5.6 million.¹ Minerva will host a KOL event on roluperidone in New York on November 12, 2026.