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Minerva Neurosciences, Inc. reports clinical and corporate updates as a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders. Company news centers on roluperidone, its product candidate for negative symptoms of schizophrenia, including confirmatory Phase 3 activity, clinical safety data, pharmacokinetic and pharmacodynamic findings, and discussions related to trial design.
Recurring updates also cover financial results, research and development spending, private financing tied to the roluperidone program, investor and scientific conference participation, and governance changes. Minerva’s disclosures are focused on the development path for CNS product candidates rather than commercial product sales.
Minerva Neurosciences (Nasdaq:NERV) has formed a Scientific Advisory Board (SAB) to guide development of roluperidone and its broader R&D pipeline.
The SAB will advise on the ongoing Phase 3 confirmatory trial (NCT07565428; MIN-101C19) for negative symptoms of schizophrenia, where no therapy is currently approved in the U.S.
Minerva Neurosciences (Nasdaq:NERV), a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders, will participate in the 2026 Jefferies Global Healthcare Conference in New York from June 2-4, 2026.
CEO Remy Luthringer will join a fireside chat on June 4 at 4:20 PM ET, with a live webcast and a 90-day replay available.
Minerva Neurosciences (Nasdaq: NERV) initiated a global confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia and screened the first patient in March 2026. The trial will enroll ~380 patients across ~40 sites with 12-week primary efficacy readout and topline data expected in 2H 2027.
Q1 2026 GAAP net loss was $125.4M ($2.86/sh), driven largely by a $109.4M non-cash warrant liability change; cash totaled $78.2M at March 31, 2026.
Minerva Neurosciences (Nasdaq: NERV) announced a leadership transition: Jim O’Connor will join as Chief Business Officer and General Counsel, effective April 21, 2026, while President Geoff Race has elected to leave and will remain engaged as a consultant. The company said the board has confidence in O’Connor to advance roluperidone into the next planned Phase 3 trial.
Minerva Neurosciences (Nasdaq: NERV) screened the first patient in its global confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia on March 31, 2026. The trial will enroll ~380 patients across ~40 sites including the US and Europe.
The study follows prior pivotal Phase 2b and Phase 3 trials that showed consistent improvements at the 64 mg dose. Efficacy topline data are expected in 2H 2027, and the design reflects prior FDA discussions.
Minerva Neurosciences (Nasdaq: NERV) presented results from an open‑label safety trial of roluperidone co‑administered with olanzapine at SIRS 2026.
The trial reported no clinically significant adverse effects, no meaningful pharmacokinetic changes, and no pharmacodynamic changes during combined administration. A confirmatory Phase 3 is enrolling with topline data anticipated in H2 2027.
Minerva Neurosciences (Nasdaq: NERV) will present at The Stifel 2026 Virtual CNS Forum on March 18, 2026 at 8:30 AM ET.
Remy Luthringer, PhD, Executive Chairman & CEO, will deliver the company presentation; a replay will be available on the company’s Investors & Media Events and Presentations webpage for ninety days.
Minerva Neurosciences (Nasdaq: NERV) reported Q4 and FY2025 results and business updates on March 11, 2026. The company completed an $80.0M upfront private placement with potential additional proceeds up to $120.0M contingent on warrant exercises and trial outcomes.
Minerva plans to initiate a confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia in Q2 2026 (~380 patients, 12-week primary endpoint) with topline data expected in 2H 2027. Cash was ~$82.4M at December 31, 2025; GAAP net loss for 2025 was $293.4M driven by non-cash preferred stock and warrant accounting.
Minerva Neurosciences (Nasdaq: NERV) announced that Remy Luthringer, PhD, Executive Chairman & Chief Executive Officer, will present at The Citizens Life Sciences Conference in Miami on March 10-11, 2026.
The company will deliver a company presentation on Tuesday, March 10 at 9:35 AM ET; a live webcast and a replay available for ninety days will be provided, according to the company.
Minerva Neurosciences (NASDAQ: NERV) will host a virtual key opinion leader event on Feb 3, 2026 at 10:30 AM ET to discuss roluperidone and the unmet need of negative symptoms of schizophrenia. Speakers Gregory Strauss, PhD, and Brian Kirkpatrick, MD, MSPH, will join management to review patient burden, assessment challenges in the current regulatory environment, and how Minerva's planned confirmatory Phase 3 trial in 2026 uses a novel protocol aligned with FDA considerations to maximize the probability of success. A live Q&A will follow the presentations.