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 (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.
Minerva Neurosciences (NASDAQ: NERV) announced significant updates regarding the development of roluperidone for treating negative symptoms in schizophrenia. Following a Type C meeting with the FDA on March 2, 2022, the FDA acknowledged the need for effective treatments addressing these symptoms but raised concerns over the applicability of past studies and efficacy data. Despite previous setbacks, Minerva remains committed to submitting a New Drug Application (NDA) for roluperidone this summer, provided additional supportive data can be acquired. The company will discuss further details in a webcast on April 13, 2022.
Minerva Neurosciences (NASDAQ: NERV) reported a net loss of $21.3 million in Q4 2021, a significant increase from a $7.3 million loss in Q4 2020. For the full year, the company incurred a loss of $49.9 million compared to a net income of $1.9 million in 2020. Collaborative revenue dropped to $0 from $41.2 million in the previous year due to a strategic opt-out from a co-development agreement. The company's cash reserves grew to $60.9 million, aided by a $60 million payment from Royalty Pharma. The firm is poised for a potential NDA submission of roluperidone in H1 2022, following a Type C meeting with the FDA.
Minerva Neurosciences announced promising results from its Phase 3 trial of roluperidone for treating negative symptoms in schizophrenia, published in Schizophrenia Bulletin. Involving 513 patients, the study demonstrated that a 64 mg dose significantly improved scores on the Personal and Social Performance scale compared to placebo (p ≤0.021). However, the primary endpoint achieved only nominal significance (p ≤0.044). Despite previous FDA setbacks, the company anticipates submitting a New Drug Application in H1 2022, aiming to fill an unmet need in schizophrenia treatment.
Minerva Neurosciences (NERV) reported third-quarter results, showing a net loss of $9.2 million, or $0.22 per share, compared to a loss of $8.1 million, or $0.19 per share, in Q3 2020. The company plans to request a Type C meeting with the FDA regarding its drug roluperidone, after the FDA denied a pre-NDA meeting request. Cash and equivalents totaled approximately $65.7 million as of September 30, 2021. Key management promotions were also announced, aimed at supporting FDA interactions.
Minerva Neurosciences (Nasdaq: NERV) announced that the FDA denied its request for a pre-NDA meeting for roluperidone and suggested a Type C guidance meeting instead. This meeting will focus on the use of roluperidone as monotherapy for schizophrenia's negative symptoms. Despite this setback, the company maintains its planned NDA submission timeline for the first half of 2022. Currently, no approved treatments exist for the negative symptoms of schizophrenia, highlighting the therapeutic potential of roluperidone.
Minerva Neurosciences (NASDAQ: NERV) will release its Q3 2021 financial results on November 8, 2021. A conference call is scheduled for 8:30 a.m. ET to discuss the results and business updates.
The company, focused on developing therapies for CNS disorders, is currently advancing its pipeline, including roluperidone for schizophrenia and MIN-301 for Parkinson's disease.
Investors can access the live call by dialing (877) 312-5845 (US) or (765) 507-2618 (international).
Minerva Neurosciences has announced leadership changes as part of its strategic plan, promoting Geoff Race to President and Frederick Ahlholm to Chief Financial Officer, effective immediately. These changes come as the company prepares to submit a pre-NDA meeting request to the FDA, aiming for a potential NDA submission in the first half of 2022. Dr. Remy Luthringer expressed confidence in the new leadership to advance the development of roluperidone for treating negative symptoms of schizophrenia. Minerva continues to focus on developing therapies for CNS disorders.
Minerva Neurosciences (Nasdaq: NERV) announced successful results from a pivotal bioequivalence study for roluperidone, aimed at treating negative symptoms of schizophrenia. The study met all key pharmacokinetic objectives, demonstrating bioequivalence between formulations used in late-stage trials and the planned commercial version. This progress is crucial for the upcoming NDA submission to the FDA. The study involved 48 healthy volunteers, confirming that the formulations can be administered with or without food, addressing FDA observations from a prior meeting.
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