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 (Nasdaq: NERV) has entered an agreement with Royalty Pharma (Nasdaq: RPRX) to sell its royalty interest in seltorexant for $60 million upfront and up to $95 million in milestone payments. Seltorexant is in Phase 3 development targeting major depressive disorder with insomnia. The funds will support Minerva's lead compound, roluperidone, also in Phase 3 for schizophrenia. Minerva will earn mid-single digit royalties on seltorexant's net sales, enhancing its financial position.
Minerva Neurosciences (NASDAQ: NERV) announced it received meeting minutes from the FDA regarding its investigation of roluperidone for negative symptoms in schizophrenia. The FDA raised concerns about the Phase 2b and Phase 3 studies, indicating that the data may not support an NDA submission due to insufficient evidence of effectiveness and the lack of adequate trials. However, Minerva intends to bridge the data gap with additional studies and is optimistic about addressing FDA concerns, continuing its development efforts.
Minerva Neurosciences (NASDAQ: NERV) announced its participation in the Jefferies Virtual London Healthcare Conference on November 17, 2020, at 12:55 p.m. GMT (7:55 a.m. EST). The presentation will be available as a live webcast and can be accessed through the company’s investor relations website. Minerva focuses on developing innovative therapies for CNS disorders, with key compounds including roluperidone for schizophrenia and MIN-301 for Parkinson’s disease. For further details, visit the company's website.
Minerva Neurosciences (NASDAQ: NERV) reported its Q3 2020 financial results, revealing a net loss of $8.1 million, significantly improved from a loss of $14.0 million in Q3 2019. Collaborative revenue surged to $41.2 million, attributed to the termination of a licensing agreement with Janssen. R&D expenses dropped to $4.6 million, while G&A expenses decreased to $3.5 million. The FDA has granted a Type C meeting for roluperidone on November 10, 2020, to discuss clinical data and potential NDA submission. An update is expected in December 2020.
Minerva Neurosciences (NASDAQ: NERV) will release its third-quarter 2020 financial results on November 2, 2020, at 8:30 a.m. ET. The conference call will provide business updates and insights into their clinical-stage biopharmaceutical developments targeting central nervous system disorders. Key products in their portfolio include roluperidone for schizophrenia and MIN-301 for Parkinson’s disease. Investors can access the call by dialing the provided numbers and a webcast will be available for later viewing.
Minerva Neurosciences, a clinical-stage biopharmaceutical company, will participate in Citi's 15th Annual BioPharma Virtual Conference on September 9, 2020, at 1:30 p.m. ET. The panel discussion focuses on "Emerging Therapies for Psychiatric Disorders." Investors can access the presentation live and on-demand via the company's website. Minerva’s product pipeline includes roluperidone for schizophrenia and seltorexant for insomnia, with additional projects targeting Parkinson’s disease.
Minerva Neurosciences, a clinical-stage biopharmaceutical firm focused on CNS disorders, will present at the JMP Securities CNS Forum on August 19, 2020, at 10:30 a.m. ET. This virtual event will be accessible via a webcast on the company's investor relations website. Minerva's product pipeline includes roluperidone for schizophrenia, seltorexant for insomnia and MDD, and MIN-301 for Parkinson's disease. The stock trades on NASDAQ under the symbol NERV.
Minerva Neurosciences (NASDAQ: NERV) reported Q2 2020 financial results, highlighting a net income of $29.5 million, or $0.75 per share, a turnaround from a loss of $12.5 million in the same period last year. The company recognized $41.2 million in collaborative revenue following its decision to opt out of the seltorexant agreement with Janssen. R&D expenses dropped to $5.8 million from $8.3 million year-over-year. However, the Phase 3 trial for roluperidone did not meet its primary endpoints, though some statistically significant improvements were observed.
Minerva Neurosciences (NASDAQ: NERV) announced a webcast on June 5, 2020, to present additional results from its Phase 3 trial focusing on negative symptoms of schizophrenia. This event replaces a previously scheduled session and will feature key opinion leaders who will discuss the findings. The company continues to develop roluperidone, a candidate for schizophrenia, alongside other compounds for insomnia and Parkinson's disease. Investors can participate via a conference call or listen to the live webcast, with an archived version available for 90 days.
Minerva Neurosciences announced that the Phase 3 trial for roluperidone to treat negative symptoms of schizophrenia did not meet its primary endpoint, which was the reduction in the PANSS Marder Negative Symptoms Factor Score. Both the 32 mg and 64 mg doses showed no significant difference from placebo at Week 12. However, the 64 mg dose demonstrated statistically significant effects at earlier time points, indicating potential efficacy. The drug was generally well tolerated, with adverse events comparable to placebo. The company plans to consult with the FDA regarding further development.
FAQ
What is the current stock price of Minerva Neurosciences (NERV)?
What is the market cap of Minerva Neurosciences (NERV)?
What is Minerva Neurosciences, Inc.?
What are the main products developed by Minerva Neurosciences?
What is Roluperidone?
What are negative symptoms of schizophrenia?
What stage is Seltorexant in?
Who are Minerva's partners?
What financial steps has Minerva taken recently?
What is MIN-301?
What challenges has Minerva faced with the FDA?
What is Minerva's long-term goal?
