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Minerva Neurosciences, Inc. reports clinical and corporate updates as a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders. Company news centers on roluperidone, its product candidate for negative symptoms of schizophrenia, including confirmatory Phase 3 activity, clinical safety data, pharmacokinetic and pharmacodynamic findings, and discussions related to trial design.
Recurring updates also cover financial results, research and development spending, private financing tied to the roluperidone program, investor and scientific conference participation, and governance changes. Minerva’s disclosures are focused on the development path for CNS product candidates rather than commercial product sales.
Minerva Neurosciences, Inc. (Nasdaq: NERV) reported its Q4 and full-year 2022 financial results and business updates. The company experienced a net loss of $6.7 million in Q4 2022, significantly down from a loss of $21.3 million in Q4 2021. The annual net loss was $32.1 million, compared to $49.9 million in 2021. Research and development expenses decreased to $3.2 million in Q4 from $18.7 million, largely due to a prior year impairment charge. Cash reserves were approximately $36.2 million as of December 31, 2022. The company remains focused on the regulatory path for its lead drug, roluperidone, which faced a Refuse to File letter from the FDA last fall, indicating ongoing dialogue with the agency.
Minerva Neurosciences (Nasdaq: NERV) announced it will release its fiscal year 2022 financial results and business updates on March 8, 2023. A conference call will follow on the same day at 8:30 a.m. Eastern Time. The company focuses on developing therapies for central nervous system disorders. Its product candidates include roluperidone for schizophrenia and MIN-301, currently in pre-clinical development for Parkinson’s disease. Details of the live webcast and subsequent archived session are available on the company’s website.
Minerva Neurosciences (Nasdaq: NERV) announced that the FDA confirmed their refuse to file letter regarding the New Drug Application (NDA) for roluperidone, intended for treating negative symptoms in schizophrenia. This outcome follows a Type A meeting held on November 30, 2022. CEO Dr. Remy Luthringer expressed disappointment but highlighted plans to continue working with the FDA for feedback and assess next steps. Current research indicates a significant patient group suffers from moderate to severe negative symptoms, for which no approved treatments exist in the U.S.
Minerva Neurosciences (NERV) announced its Q3 2022 financial results, reporting a net loss of $6.9 million or $1.29 per share, down from a net loss of $9.2 million in Q3 2021. The R&D expense decreased to $2.4 million, as compared to $4.5 million in the same period last year. The company experienced a decrease in total cash to approximately $40.3 million as of September 30, 2022. Following a refusal from the FDA for their NDA submission regarding roluperidone for schizophrenia, the company has requested a Type A meeting with the FDA.
Minerva Neurosciences (Nasdaq: NERV) announced it will release financial results for Q3 2022 on November 9, 2022. A webcast is scheduled for 8:30 a.m. Eastern Time to discuss these results and business updates. The archived version of the webcast will be available on the company’s website for 90 days post-event.
Minerva focuses on developing therapies for central nervous system disorders, including its lead candidate roluperidone for schizophrenia and MIN-301 for Parkinson's disease.
Minerva Neurosciences, Inc. (Nasdaq: NERV) announced it received a refusal to file letter from the FDA regarding its New Drug Application for roluperidone, intended for treating negative symptoms in schizophrenia patients. The FDA's letter prompts the company to request a Type A meeting to discuss the reasons for refusal. This setback is disappointing as there are currently no approved therapies in the U.S. for these symptoms, affecting millions globally. Minerva's continued commitment aims to provide essential therapeutic options for patients.
Minerva Neurosciences (Nasdaq: NERV) announced its transfer from The Nasdaq Global Market to The Nasdaq Capital Market, effective September 12, 2022. This transfer follows the approval of its application by Nasdaq, allowing the company to maintain compliance with listing requirements after a notice of non-compliance regarding minimum net equity. The transfer does not affect trading under the symbol 'NERV' and signifies that Minerva meets the financial standards of the Capital Market. The company focuses on developing therapies for central nervous system disorders.
Minerva Neurosciences (Nasdaq: NERV) has submitted a New Drug Application (NDA) to the FDA for roluperidone, targeting negative symptoms in schizophrenia. This submission stems from two late-stage studies (MIN-101C03 and MIN-101C07), demonstrating significant efficacy with the 64 mg dose. Results indicate statistically significant improvements in negative symptoms compared to placebo. The company is optimistic about satisfying FDA criteria, addressing an urgent need as there are currently no approved treatments for these symptoms in the U.S.
Minerva Neurosciences (NERV) reported its Q2 2022 results, showcasing a net loss of $8.7 million ($1.63 per share), an improvement from a net loss of $10.6 million in Q2 2021. The company is preparing for a potential NDA submission for roluperidone aimed at addressing negative symptoms in schizophrenia, with expectations set for Q3 2022. R&D expenses decreased to $4.1 million from $5.5 million year-over-year, while G&A expenses also fell to $2.8 million. However, total cash reserves have decreased to $49.9 million from $60.9 million since December 2021.
Minerva Neurosciences, Inc. (Nasdaq: NERV) reported its first quarter 2022 financial results, highlighting a net loss of $9.8 million, or $0.23 per share, compared to a net loss of $8.8 million, or $0.21 per share for the same period in 2021. R&D expenses rose to $5.0 million due to NDA support activities, while G&A expenses decreased to $3.0 million. The company is preparing to submit a New Drug Application for roluperidone in Q3 2022, following a productive meeting with the FDA. Minerva's cash position stood at $55.0 million as of March 31, 2022.