Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of product candidates for the treatment of central nervous system diseases. Its lead product candidate is roluperidone, a compound in Phase III clinical trial for the treatment of schizophrenia; and MIN-301, a soluble recombinant form of the neuregulin-1b1 protein for the treatment of Parkinson's disease and other neurodegenerative disorders. Minerva Neurosciences, Inc. has a license agreement with Mitsubishi Tanabe Pharma Corporation to develop, sell, and import roluperidone globally excluding Asia. The company was formerly known as Cyrenaic Pharmaceuticals, Inc. and changed its name to Minerva Neurosciences, Inc. in 2013. Minerva Neurosciences, Inc. was incorporated in 2007 and is headquartered in Waltham, Massachusetts.
IPO Year: 2014
Exchange: NASDAQ
Website: minervaneurosciences.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 3/4/2022 | $10.00 → $5.00 | Buy | HC Wainwright & Co. |
10-Q - Minerva Neurosciences, Inc. (0001598646) (Filer)
10-K/A - Minerva Neurosciences, Inc. (0001598646) (Filer)
10-K/A - Minerva Neurosciences, Inc. (0001598646) (Filer)
8-K - Minerva Neurosciences, Inc. (0001598646) (Filer)
10-K - Minerva Neurosciences, Inc. (0001598646) (Filer)
8-K - Minerva Neurosciences, Inc. (0001598646) (Filer)
8-K - Minerva Neurosciences, Inc. (0001598646) (Filer)
10-Q - Minerva Neurosciences, Inc. (0001598646) (Filer)
DEFA14A - Minerva Neurosciences, Inc. (0001598646) (Filer)
DEF 14A - Minerva Neurosciences, Inc. (0001598646) (Filer)
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
SC 13G/A - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G/A - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13D - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G/A - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G/A - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G/A - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G/A - Minerva Neurosciences, Inc. (0001598646) (Subject)
SC 13G/A - Minerva Neurosciences, Inc. (0001598646) (Subject)
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
BURLINGTON, Mass., Nov. 05, 2024 (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 business updates and financial results for the third quarter of 2024 ending September 30, 2024. Roluperidone NDA Update As announced in February 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to our New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. Interactions with the FDA continue with the goal of addressing questions rais
BURLINGTON, Mass., Aug. 06, 2024 (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 business updates and financial results for the second quarter of 2024 ending June 30, 2024. Roluperidone NDA Update During the first quarter of this year, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. Since receiving the CRL, the Company has cont
BURLINGTON, Mass., May 01, 2024 (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 business updates and financial results for the first quarter of 2024 ending March 31, 2024. Roluperidone NDA Update On February 27, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. The Company is in discussions with the FDA regarding the issues and
BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company's New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. In the CRL, the FDA cited the following clinical deficiencies: Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidenc
BURLINGTON, Mass., Nov. 07, 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 third quarter ended September 30, 2023. The Company continues to work with the U.S. Food and Drug Administration (FDA) during its review of its New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia, in advance of the February 26, 2024 PDUFA date. "We remain committed to bringing roluperidone to patients and physicians as we believe it addresses a significant un
BURLINGTON, Mass., Aug. 01, 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 second quarter ended June 30, 2023. "In the second quarter, we completed an equity financing of $20.0 million, further strengthening our cash position. This investment from Boehringer Ingelheim and Federated Hermes Kaufman Funds comes as we continue to interact with the FDA in support of their review of our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophren
BURLINGTON, Mass., June 28, 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 announced that it has agreed to sell an aggregate of 1,425,000 shares of its common stock at a purchase price of $10 per share and pre-funded warrants to purchase an aggregate of 575,575 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, to Boehringer Ingelheim, a global biopharmaceutical company with a growing mental health pipeline that includes schizophrenia, and Federated Hermes Kaufmann Funds in a private investment in public equity
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 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
BURLINGTON, Mass., March 01, 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 fiscal year 2022 financial results and business updates on Wednesday, March 8, 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 M
BURLINGTON, Mass., Nov. 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 key business updates and financial results for the quarter ended September 30, 2022. Roluperidone Update As announced on August 17, 2022, the company submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for roluperidone to treat negative symptoms in schizophrenia. The submission included data from two clinical trials, the company's phase 2b and phase 3 studies, in patients diagnosed with schizophrenia with negative sy
BURLINGTON, Mass., Nov. 02, 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 it will release financial results and business updates for the third quarter of 2022 on Wednesday, November 9, 2022. 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 the webcast is available on the Company's website under Events and Presentations. The archived webcast will be available on the Company's website beginning approximately two
Company to Host Conference Call Today at 8:30 a.m. ET WALTHAM, Mass., Nov. 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 reported key business updates and financial results for the quarter ended September 30, 2021. Roluperidone Update On November 3, 2021, the Company announced that the U. S. Food and Drug Administration (FDA) 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 roluperido
WALTHAM, Mass., Nov. 01, 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 it will release financial results and business updates for the third quarter of 2021 on Monday, November 8, 2021. The Company will host a webcast and conference call that day at 8:30 a.m. Eastern Time to discuss these results and updates. The live call may be accessed by dialing (877) 312-5845 (US and Canada) or (765) 507-2618 (international) and referring to conference ID number 3775536. The live webcast of the conference call can also be accesse
WALTHAM, Mass., Aug. 02, 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 reported key business updates and financial results for the quarter ended June 30, 2021. Roluperidone Update Following the completion of the open-label portion of the Phase 3 trial with roluperidone in schizophrenia and the Type C meeting with the U.S. Food and Drug Administration (FDA), the Company continues to work towards the submission of a New Drug Application (NDA) in the first half of 2022. On June 29, 2021, the Company completed the enrollment of 48 su
WALTHAM, Mass., July 26, 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 it will release financial results and business updates for the second quarter of 2021 on Monday, August 2, 2021. The Company will host a webcast and conference call that day at 8:30 a.m. Eastern Time to discuss these results and updates. The live call may be accessed by dialing (877) 312-5845 (domestic) or (765) 507-2618 (international) and referring to conference ID number 4327209. A live webcast of the conference call will be available online in
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
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