Amendment: SEC Form SC 13G/A filed by Minerva Neurosciences Inc
$NERV
Biotechnology: Pharmaceutical Preparations
Health Care
Stay ahead of the competition with Standout.work - your AI-powered talent-to-startup matching platform.
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 3/4/2022 | $10.00 → $5.00 | Buy | HC Wainwright & Co. |
FDA confirms requirement for confirmatory study of roluperidone for the treatment of negative symptoms in schizophrenia Evaluation of strategic alternatives BURLINGTON, Mass., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today provided business updates. FDA Discussions & Roluperidone Update The Company has had multiple interactions with the FDA following receipt of the Complete Response Letter (CRL) for its New Drug Application (NDA) in February 2024 and the FDA has confirmed the requirement for an additional confirmatory
BURLINGTON, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter of 2025 ended on March 31, 2025. Corporate Update On March 17, 2025, we were formally notified by Nasdaq that we had regained compliance with Nasdaq Listing Rule 5550(b)(3), and as such, will continue to be listed on the Nasdaq Capital Market. Interactions with the FDA continue with the goal of addressing questions raised in the Complete Response Letter (CRL) to our New Drug Application
BURLINGTON, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the fourth quarter and year ended December 31, 2024. Corporate Update As previously disclosed in the first quarter of 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. The company continues to have interactions with the FDA with the goal of addressing
HC Wainwright & Co. reiterated coverage of Minerva Neurosciences with a rating of Buy and set a new price target of $5.00 from $10.00 previously
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
10-Q - Minerva Neurosciences, Inc. (0001598646) (Filer)
10-Q - Minerva Neurosciences, Inc. (0001598646) (Filer)
10-K/A - Minerva Neurosciences, Inc. (0001598646) (Filer)
BURLINGTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter ended March 31, 2023. "The first quarter saw the achievement of a significant milestone for our investigational drug, roluperidone, and for Minerva, as the U.S. Food and Drug Administration (FDA) filed our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia on April 27, 2023. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of
BURLINGTON, Mass., May 08, 2023 (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 it will release first quarter 2023 financial results and business updates on Monday, May 15, 2023. The Company will host a webcast that day at 8:30 a.m. Eastern Time to discuss the results and updates. The live conference call may be accessed here and on the Company's website under Events and Presentations. The archived webcast will be available on the Company's website beginning approximately two hours after the event for 90 days. About Miner
BURLINGTON, Mass., March 08, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the fourth quarter and year ended December 31, 2022. Corporate Update "In 2022, we had multiple interactions with the FDA regarding the regulatory path forward for our lead compound, roluperidone. After submitting an NDA for roluperidone to the FDA in August, we received a Refuse to File letter (RTF) in the fall, which was upheld following another meeting with the FDA. We remain committed to developing roluperid
SC 13G/A - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G/A - Minerva Neurosciences, Inc. (0001598646) (Subject)
Frederick Ahlholm is Named Chief Financial Officer as Company Prepares to Submit a Pre-NDA Meeting Request to FDA WALTHAM, Mass., Oct. 11, 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 Geoff Race, current Executive Vice President, Chief Financial Officer and Chief Business Officer of Minerva, has been promoted to President. Minerva's Senior Vice President and Chief Accounting Officer, Frederick Ahlholm, has been promoted to Chief Financial Officer. The appointments are effective immediately. These latest leadership
WALTHAM, Mass., Sept. 08, 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 Dr. Jay Saoud's retirement and transition to an advisory role and Dr. Ramana Kuchibhatla's appointment as Senior Vice President and Head of Research & Development, both effective September 16, 2021. Dr. Kuchibhatla will report directly to Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. "I would like to thank Jay for the invaluable skill and leadership which have enabled Minerva to take roluperidone from early stage cl