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
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,
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.
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
Company to host conference call at 8:30 a.m. today (dial-in information below) WALTHAM, Mass. , Oct. 01, 2019 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS)
BURLINGTON, Mass., Dec. 28, 2022 (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, following the Type A meeting held on November
FDA confirms acceptance of the filing of the NDA for roluperidone Application has been granted a standard review FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024 BURLINGTON, Mass., May 10, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc.
