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. reported its first-quarter 2024 financial results, including an update on the roluperidone NDA and completion of a Phase 1b clinical trial for patients with schizophrenia. The company's R&D expenses increased due to FDA review costs, while G&A expenses decreased. The net loss for the quarter was $8.6 million. Cash position decreased to $34.9 million.
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