Business
Minerva Neurosciences Reports 2023 First Quarter Financial Results and Business Updates
Company to host conference call today at 8:30 a.m. ET BURLINGTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a
About this update from Minerva Neurosciences, Inc
[{"type":"text","content":"Company to host conference call today at 8:30 a.m. ET\nBURLINGTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter ended March 31, 2023. “The first quarter saw the achievement of a significant milestone for our investigational drug, roluperidone, and for Minerva, as the U.S. Food and Drug Administration (FDA) filed our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia on April 27, 2023. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024. We believe roluperidone has a unique mechanism of action and is intended to treat a group of patients that, to date, have not had an approved treatment. This is a completely new approach to treating negative symptoms of schizophrenia and we look forward to continuing to work with the FDA as they undertake their review. “Successfully treating the negative symptoms of schizophrenia has historically been a significant challenge. If approved, roluperidone will be the first approved treatment for negative symptoms of schizophrenia in the U.S. We believe it has the potential to beneficially impact patients’ quality of life, reduce the burden on families and caregivers and provide physicians with a new treatment option,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. Recent Business Highlights The Company submitted a Formal Dispute Resolution Request (FDRR) on March 2, 2023, and met with the FDA on March 28, 2023. At the meeting the Company presented a detailed summary of data to address the issues raised in the Refuse to File letter (RTF) received by the Company in October 2022.On April 27, 2023, the FDA confirmed filing of Minerva’s NDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia.On May 8, 2023, the FDA confirmed that they had assigned a PDUFA goal date of February 26, 2024. First Quarter 2023 Financial Results Research and development (R&D) expense: Research and development expenses were $2.7 million and $5.0 million for the three months ended March 31, 2023 and 2022, respectively, a decrease of ...