Welcome to our dedicated page for Minerva Neurosciences news (Ticker: NERV), a resource for investors and traders seeking the latest updates and insights on Minerva Neurosciences stock.
Minerva Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing therapeutics for central nervous system (CNS) diseases. The company’s primary focus lies in addressing unmet medical needs within the realm of schizophrenia, depressive disorders, insomnia, and Parkinson's disease.
Minerva's lead product candidate, Roluperidone, is currently in a phase III clinical trial aimed at treating negative symptoms of schizophrenia. If approved, Roluperidone could be the first-ever treatment specifically targeting these symptoms, which include social withdrawal and lack of emotional expression.
In addition to Roluperidone, Minerva is advancing Seltorexant, a compound that has completed phase IIb clinical trials for the treatment of insomnia and major depressive disorders. Another significant asset in its pipeline is MIN-301, a pre-clinical trial product targeted at Parkinson's disease, involving a soluble recombinant form of the neuregulin-1b1 protein.
Minerva Neurosciences has forged significant partnerships to bolster its development efforts. The company has a license agreement with Mitsubishi Tanabe Pharma Corporation for the global development and commercialization of Roluperidone (excluding Asia), and a co-development and license agreement with Janssen Pharmaceutica, N.V. for developing Seltorexant.
Financially, Minerva Neurosciences has strengthened its position through recent equity financings, including a $20 million investment from Boehringer Ingelheim and Federated Hermes Kaufman Funds. This capital infusion supports ongoing interactions with the U.S. Food and Drug Administration (FDA) concerning the New Drug Application (NDA) for Roluperidone.
Despite facing regulatory challenges, such as the issuance of a Complete Response Letter (CRL) from the FDA for Roluperidone, Minerva remains committed to addressing the deficiencies and advancing its promising pipeline. The company's ultimate goal is to transform the lives of patients by providing improved therapeutic options for CNS diseases.
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.
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