Press Releases

Date Title and Summary Additional Formats
Toggle Summary Minerva Neurosciences Announces Top Line Data From MIN-202 Phase I Clinical Study in Japanese Patients View HTML
Toggle Summary Minerva Neurosciences Announces the Results of the Phase 3 Trial of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia Following the Completion of the 40-Week Open-Label Extension
Key results Continuous improvement in negative symptoms as measured by Positive and Negative Syndrome Scale (PANSS) Marder Negative Symptom Factor Score (NSFS) observed over one year (12-week double-blind and 40-week open-label periods) in patients receiving both 64 mg and 32 mg doses Continuous
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Toggle Summary Minerva Neurosciences Announces the NDA Filing for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
FDA grants appeal and files NDA BURLINGTON, Mass., May 01, 2023 (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 announced that the U.S.
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Toggle Summary Minerva Neurosciences Announces Study Results Demonstrating Bioequivalence of Phase 2b, Phase 3, and Planned Commercial Formulations of Roluperidone for Treatment of Negative Symptoms of Schizophrenia
Company to Request Pre-NDA Meeting with U.S. Food and Drug Administration WALTHAM, Mass. , Sept. 30, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders,
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Toggle Summary Minerva Neurosciences Announces Results of Dose Escalation Study Evaluating Roluperidone (MIN-101) Administered at Supra-Therapeutic Doses in Healthy Volunteers
Findings suggest expanded therapeutic window and significantly improved cardiovascular safety margin compared to formulation used in Phase 2b trial   All doses tested up to 256 milligrams appear safe and well tolerated with no significant changes in cardiac repolarization and QTc intervals   Tested
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Toggle Summary Minerva Neurosciences Announces Results From Phase 3 Trial of Roluperidone (MIN-101) for Treatment of Negative Symptoms in Schizophrenia
The 64 mg and 32 mg doses were not statistically significantly different from placebo at Week 12 on the primary endpoint, the PANSS Marder Negative Symptoms Factor Score (p ≤0.064 and 0.259, respectively), or the key secondary endpoint, the Personal and Social Performance Scale Total Score (p
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Toggle Summary Minerva Neurosciences Announces Recent Exercise of Warrants by Institutional Stockholders and Open Market Purchase of Common Stock by Chairman of Its Board of Directors View HTML
Toggle Summary Minerva Neurosciences Announces Publication of Roluperidone Phase 3 Study Results in Schizophrenia Bulletin
Trial Results Confirm the Potential of Roluperidone To Treat Negative Symptoms and Improve Everyday Functioning in Patients with Schizophrenia WALTHAM, Mass., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the
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Toggle Summary Minerva Neurosciences Announces Proposed Public Offering of Common Stock View HTML
Toggle Summary Minerva Neurosciences Announces Promotion of Geoff Race to President
Frederick Ahlholm is Named Chief Financial Officer as Company Prepares to Submit a Pre-NDA Meeting Request to FDA WALTHAM, Mass. , Oct. 11, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to
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