Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of a portfolio of product candidates to treat central nervous system diseases. It develops Roluperidone for the treatment of negative symptoms in patients with schizophrenia and MIN-301 for the treatment of Parkinson’s disease. The company was founded by Rogerio Vivaldi Coelho and Goeffrey Robin Race on April 23, 2007 and is headquartered in Waltham, MA.

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Minerva Neurosciences faces FDA challenges with roluperidone in Q4

Minerva Neurosciences' Q4 2022 earnings call highlighted challenges with FDA interactions for roluperidone, alongside financial updates. Despite hurdles, the company expressed confidence in its data package and the potential of roluperidone to meet medical needs. Ongoing FDA dialogue remains critical for addressing regulatory concerns and advancing the schizophrenia treatment.

Minerva Neurosciences advances NDA filing for roluperidone, faces regulatory challenges

Minerva Neurosciences showcased progress in drug development and financial stability while facing challenges in regulatory processes and financial uncertainties. The company's strategic focus on unique drug profiles and milestone achievements presents opportunities for growth and market success.

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Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of a portfolio of product candidates to treat central nervous system diseases. It develops Roluperidone for the treatment of negative symptoms in patients with schizophrenia and MIN-301 for the treatment of Parkinson’s disease. The company was founded by Rogerio Vivaldi Coelho and Goeffrey Robin Race on April 23, 2007 and is headquartered in Burlington, MA.

Minerva Neurosciences Inc. NERV, +7.61% said Monday that it received a refusal to file letter from the Food and Drug Administration for its application for roluperidone as a treatment for patients with schizophrenia. "The company intends to request a Type A meeting and looks forward to continued discussions with the FDA," Minerva CEO said in a news release.

Minerva Neurosciences to request meeting with FDA about schizophrenia drug

BURLINGTON, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.

Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

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BURLINGTON, Mass., Sept. 09, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported a listing transfer from The Nasdaq Global Market to The Nasdaq Capital Market.

Minerva Neurosciences Announces Listing Transfer to Nasdaq Capital Market

Shares of Minerva Neurosciences (NASDAQ: NERV ) are soaring higher by over 70%  following a purchase by Steve Cohen's Point72 Asset Management and the company's submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA). The NDA pertains to Minerva's roluperidone, which seeks to treat symptoms in patients with schizophrenia.

Billionaire Steven Cohen Just Made a Big Bet on Minerva Neurosciences (NERV) Stock

Minerva's (NERV) stock surges after the company files an NDA-seeking FDA approval for its schizophrenia therapy.

Minerva (NERV) Submits NDA for Schizophrenia Candidate, Stock Up

WALTHAM, Mass., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. The roluperidone clinical development program aims to provide effective treatment for negative symptoms of schizophrenia, a significant unmet medical need in a large patient population.

Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

Minerva Neurosciences (NERV) appears to have found support after losing some value lately, as indicated by the formation of a hammer chart. In addition to this technical chart pattern, strong agreement among Wall Street analysts in revising earnings estimates higher enhances the stock's potential for a turnaround in the near term.

Here's Why Minerva Neurosciences (NERV) Could be Great Choice for a Bottom Fisher

Company Continues to Prepare for Potential Submission of an NDA for Roluperidone in the Third Quarter of 2022 Company Continues to Prepare for Potential Submission of an NDA for Roluperidone in the Third Quarter of 2022

Minerva Neurosciences Reports Second Quarter 2022 Financial Results and Business Updates

Company Expects to Submit an NDA for Roluperidone, Subject to FDA Guidance, in the Third Quarter of 2022 Company Expects to Submit an NDA for Roluperidone, Subject to FDA Guidance, in the Third Quarter of 2022

Minerva Neurosciences Reports First Quarter 2022 Financial Results and Business Updates

Minerva Neurosciences Inc (NASDAQ: NERV) received the official meeting minutes from the Type C meeting with the FDA regarding the development of roluperidone for negative symptoms in schizophrenia. The agency cited concerns related to the applicability of the results of the Phase 2b.

Minerva Outlines Next Steps For US Application For Schizophrenia Candidate

Company to Host Webcast Wednesday, April 13, 2022 at 11am ET Company to Host Webcast Wednesday, April 13, 2022 at 11am ET

Minerva Neurosciences Provides Update from Type C Meeting with FDA and Next Steps in Preparation for Submission of a New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

Minerva Neurosciences (NERV) delivered earnings and revenue surprises of 40% and 100%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?

Minerva Neurosciences (NERV) Reports Q4 Loss, Misses Revenue Estimates

WALTHAM, Mass., March 01, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV) a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system disorders, today reported key business updates and financial results for the fourth quarter ended December 31, 2021. The Company is not hosting a call this quarter as it prepares for a meeting with the FDA and anticipates providing an update after the meeting, as appropriate.

Minerva Neurosciences Reports Fourth Quarter 2021 Financial Results and Business Updates

Trial Results Confirm the Potential of Roluperidone To Treat Negative Symptoms and Improve Everyday Functioning in Patients with Schizophrenia Trial Results Confirm the Potential of Roluperidone To Treat Negative Symptoms and Improve Everyday Functioning in Patients with Schizophrenia

Minerva Neurosciences Announces Publication of Roluperidone Phase 3 Study Results in Schizophrenia Bulletin

Minerva Neurosciences, Inc. (NERV) CEO Remy Luthringer on Q3 2021 Results - Earnings Call Transcript

Minerva Neurosciences (NERV) delivered earnings and revenue surprises of 0.00% and -100.00%, respectively, for the quarter ended September 2021. Do the numbers hold clues to what lies ahead for the stock?

Minerva Neurosciences (NERV) Reports Q3 Loss, Misses Revenue Estimates

Company to Host Conference Call Today at 8:30 a.m. ET

Minerva Neurosciences Reports Third Quarter 2021 Financial Results and Business Updates

WALTHAM, Mass., Nov. 03, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the U. S. Food and Drug Administration (FDA) has denied the company's request for a pre-NDA meeting for roluperidone and responded that a Type C guidance meeting would be more appropriate to discuss the evidence for use of roluperidone as monotherapy. Subject to the timing of and feedback from the FDA at a Type C guidance meeting, which the Company plans to request, the Company has not changed its previously announced projected timeline for submission of the NDA in the first half of 2022.

Minerva Neurosciences Announces FDA Recommendation for Type C Meeting to Discuss Evidence for Use of Roluperidone as Monotherapy for the Treatment of Negative Symptoms in Patients with Schizophrenia in Advance of Potential NDA Submission

Management to Host Conference Call Management to Host Conference Call

Minerva Neurosciences to Report Third Quarter 2021 Financial Results and Business Updates on November 8

Frederick Ahlholm is Named Chief Financial Officer as Company Prepares to Submit a Pre-NDA Meeting Request to FDA

Minerva Neurosciences Announces Promotion of Geoff Race to President

Minerva Neurosciences Inc (NASDAQ: NERV) announced results from a bioequivalence study comparing roluperidone formulations used in Phase 2b and Phase 3 trials and the planned commercial formulation.  Related Link:   Minerva's Schizophrenia Candidate Shows Long Term Improvement In Negative Symptoms, Functioning

News for Minerva Neurosciences Stock (NERV)