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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 (NERV) reported Q3 2024 financial results with notable changes in expenses and income. R&D expenses decreased to $1.9 million from $3.4 million in Q3 2023, while G&A expenses slightly decreased to $2.5 million from $2.6 million. The company reported net income of $22.5 million for Q3 2024, compared to a net loss of $7.8 million in Q3 2023. Cash position stood at $26.6 million as of September 30, 2024. The FDA previously issued a Complete Response Letter for roluperidone's NDA for treating negative symptoms in schizophrenia patients, and the company continues interactions with the FDA to address raised questions.
Minerva Neurosciences (Nasdaq: NERV) reported its Q2 2024 financial results and business updates. Key highlights include:
1. The FDA issued a Complete Response Letter (CRL) for roluperidone's NDA for treating negative symptoms in schizophrenia patients.
2. R&D expenses increased to $3.9 million in Q2 2024 from $1.9 million in Q2 2023.
3. G&A expenses decreased to $2.4 million in Q2 2024 from $2.6 million in Q2 2023.
4. Net loss for Q2 2024 was $8.2 million ($1.09 per share) compared to $6.2 million ($1.12 per share) in Q2 2023.
5. Cash position as of June 30, 2024, was $31.0 million, down from $41.0 million on December 31, 2023.
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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