Minerva`s schizophrenia drug rejected by FDA for 2nd time
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,...
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...
BURLINGTON, Mass., Oct. 17, 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 the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.
WALTHAM, Mass., Aug. 22, 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 the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. The roluperidone clinical development program aims to provide effective treatment for negative symptoms of schizophrenia, a significant unmet medical need in a large patient population.
WALTHAM, Mass., Nov. 03, 2021 (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. Food and Drug Administration (FDA) has denied the company’s request for a pre-NDA meeting for roluperidone and responded that a Type C guidance meeting would be more appropriate to discuss the evidence for use of roluperidone as monotherapy. Subject to the timing of and feedback from the FDA at a Type C guidance meeting, which the Company plans to request, the Company has not changed its previously announced projected timeline for submission of the NDA in the first half of 2022.
WALTHAM, Mass., March 08, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system disorders, today reported key business updates and financial results for the fourth quarter and fiscal year ended December 31, 2020.
The FDA spells out 4 reasons why it hates Minerva’s NDA ideas — but the biotech is going for it anyway
Minerva Neurosciences has reported that roluperidone failed to meet endpoints in a Phase III clinical trial for the treatment of negative symptoms in schizophrenia.
Months after a depressing end to Minerva Neurosciences‘ quest to develop a depression drug, the Waltham, Massachusetts-based drug developer unveiled more bad news as its lead experimental compound — roluperidone — failed to succeed in a late-stage schizophrenia study. The Achilles heel of many a CNS failure reared its ugly head again: the dreaded larger-than-life placebo effect. But company chief Rémy Luthringer isn’t throwing in the towel just yet.