Minerva Neurosciences Reports Fiscal Year 2022 Fourth Quarter And Year End Financial Results And Business Updates

About this update from Minerva Neurosciences, Inc

[{"type":"text","content":"Company to Host Conference Call Today at 8:30 a.m. ET\nBURLINGTON, Mass., March 08, 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 fourth quarter and year ended December 31, 2022. Corporate Update “In 2022, we had multiple interactions with the FDA regarding the regulatory path forward for our lead compound, roluperidone. After submitting an NDA for roluperidone to the FDA in August, we received a Refuse to File letter (RTF) in the fall, which was upheld following another meeting with the FDA. We remain committed to developing roluperidone as a potentially transformative treatment for those patients with negative symptoms of schizophrenia and we anticipate further discussion with the FDA over the coming months,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. Roluperidone In March 2022, Minerva attended a Type C meeting with the FDA, who advised that certain concerns remained, which were outlined in our press release on April 7, 2022, specifically: The applicability of the Phase 2b data (conducted outside of the U.S). to the U.S. population;The Phase 3 study did not meet its primary endpoint;FDA sought reassurance that Minerva could reliably identify patients who do not need antipsychotics and how to evaluate the stability of those patients; andThe FDA also noted that roluperidone might be used by prescribers in a way that differs significantly from the intended monotherapy use and that the sponsor had not presented data to show that roluperidone would not interfere with the safety or efficacy of antipsychotic medications. In August 2022, the Company submitted the NDA for roluperidone. Additional data were provided which the Company believed addressed the concerns raised by FDA at the April 2022 Type C meeting. The submission was supported by results from two late-stage, well-controlled studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia.In October 2022, Minerva received a RTF from the FDA. Consequently, a Type A meeting was requested to discuss the RTF, which was held on November 30, 2022. Following the Type A meeting, the FDA con...

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