Minerva Neurosciences Reports Third Quarter 2022 Financial Results and Business Updates

About this update from Minerva Neurosciences, Inc

[{"type":"text","content":"Company To Host Live Webcast Today at 8:30 a.m. ETBURLINGTON, Mass., Nov. 09, 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 reported key business updates and financial results for the quarter ended September 30, 2022. Roluperidone Update As announced on August 17, 2022, the company submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for roluperidone to treat negative symptoms in schizophrenia. The submission included data from two clinical trials, the company’s phase 2b and phase 3 studies, in patients diagnosed with schizophrenia with negative symptoms. On October 17, 2022, the company announced that it had received a refusal to file letter from the FDA. The company has requested a Type A meeting and anticipates that the Type A meeting will occur by the end of this year. “We believe that a large subset of patients diagnosed with schizophrenia do not require continuous treatment with antipsychotics for positive symptoms yet still suffer negative symptoms. We developed roluperidone as a monotherapy for this patient sub-population. We discussed with the FDA the need for a treatment for this specific sub-population of U.S. patients and the FDA has acknowledged that negative symptoms represent a significant unmet medical need for which there are currently no approved treatments,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva Neurosciences. “While we are disappointed that the FDA did not accept our NDA for roluperidone, the Company looks forward to discussions with the FDA at the Type A meeting.” Third Quarter 2022 Financial Results Net Loss: Net loss was $6.9 million for the third quarter of 2022, or net loss per share of $1.29 basic and diluted, as compared to net loss of $9.2 million, or net loss per share of $1.72 basic and diluted, for the third quarter of 2021. Net loss was $25.4 million for the nine months ended September 30, 2022, or net loss per share of $4.75 basic and diluted, as compared to net loss of $28.6 million, or net loss per share of $5.36 basic and diluted for the nine months ended September 30, 2021.R&D Expense: For the three months ended September 30, 2022 and 2021, research and dev...

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