reports
Minerva Neurosciences Reports First Quarter 2025 Financial Results and...
Minerva Neurosciences Reports First Quarter 2025 Financial Results and Business Updates BURLINGTON, Mass., May 13, 2025 (GLOBE NEWSWIRE) -- (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...
Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2024 Fina...
Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Business Updates BURLINGTON, Mass., Feb. 25, 2025 (GLOBE NEWSWIRE) -- (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 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...
Minerva Neurosciences Reports Third Quarter 2024 Financial Results and...
Minerva Neurosciences Reports Third Quarter 2024 Financial Results and Business Updates BURLINGTON, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- (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 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 M...
Minerva Neurosciences Reports Second Quarter 2024 Financial Results an...
Minerva Neurosciences Reports Second Quarter 2024 Financial Results and Business Updates BURLINGTON, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- (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 that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Applicatio...
Minerva Neurosciences Reports First Quarter 2024 Financial Results and...
Minerva Neurosciences Reports First Quarter 2024 Financial Results and Business Updates 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 that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Applic...
Minerva Neurosciences Receives Complete Response Letter from FDA for N...
Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- (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 w...
Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2023 Fina...
Minerva Neurosciences Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Business Updates BURLINGTON, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- (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, 2023. Corporate Update On May 8 2023, the U.S. Food and Drug Administration (FDA) confirmed acceptance for filing of Minerva’s New Drug Application (NDA) for roluperidone for the treat...
Minerva Neurosciences Reports 2023 Third Quarter Financial Results and...
Minerva Neurosciences Reports 2023 Third Quarter Financial Results and Business Updates BURLINGTON, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- (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, ...
Minerva Neurosciences Reports 2023 Second Quarter Financial Results an...
Minerva Neurosciences Reports 2023 Second Quarter Financial Results and Business Updates BURLINGTON, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) -- (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...
Minerva Neurosciences Announces $20 Million in Private Placement Price...
Minerva Neurosciences Announces $20 Million in Private Placement Priced at a Premium to Market BURLINGTON, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- (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 glob...
Minerva Neurosciences Reports 2023 First Quarter Financial Results and...
Minerva Neurosciences Reports 2023 First Quarter Financial Results and Business Updates Company to host conference call today at 8:30 a.m. ET BURLINGTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- (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 Admi...
Minerva Neurosciences Announces Update on its New Drug Application (ND...
Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia FDA confirms acceptance of the filing of the NDA for roluperidone Application has been granted a standard review FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024 BURLINGTON, Mass., May 10, 2023 (GLOBE NEWSWIRE) -- (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that on May 8, 2023, it re...
Minerva Neurosciences to Report First Quarter 2023 Financial Results a...
Minerva Neurosciences to Report First Quarter 2023 Financial Results and Business Updates on May 15, 2023 Management to Host Conference Call BURLINGTON, Mass., May 08, 2023 (GLOBE NEWSWIRE) -- (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 ma...
Minerva Neurosciences Announces the NDA Filing for Roluperidone for th...
Minerva Neurosciences Announces the NDA Filing for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia FDA grants appeal and files NDA BURLINGTON, Mass., May 01, 2023 (GLOBE NEWSWIRE) -- (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) filed the Company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia on April 27, 2023. The decision to file t...
Minerva Neurosciences Reports Fiscal Year 2022 Fourth Quarter And Year...
Minerva Neurosciences Reports Fiscal Year 2022 Fourth Quarter And Year End Financial Results And Business Updates Company to Host Conference Call Today at 8:30 a.m. ET BURLINGTON, Mass., March 08, 2023 (GLOBE NEWSWIRE) -- (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 ...
Minerva Neurosciences to Report Fiscal Year 2022 Financial Results and...
Minerva Neurosciences to Report Fiscal Year 2022 Financial Results and Business Updates on March 8, 2023 Management to Host Conference Call BURLINGTON, Mass., March 01, 2023 (GLOBE NEWSWIRE) -- (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...
Minerva Neurosciences Announces Update on its New Drug Application (ND...
Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia BURLINGTON, Mass., Dec. 28, 2022 (GLOBE NEWSWIRE) -- (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that, following the Type A meeting held on November 30, 2022, the Food and Drug Administration (FDA) has confirmed that the refuse to file letter dated October 14, 2022 remains in effect in respect of the Company’s New Drug Applica...
Minerva Neurosciences Reports Third Quarter 2022 Financial Results and...
Minerva Neurosciences Reports Third Quarter 2022 Financial Results and Business Updates Company To Host Live Webcast Today at 8:30 a.m. ET BURLINGTON, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) -- (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) ...
Minerva Neurosciences to Report Third Quarter 2022 Financial Results a...
Minerva Neurosciences to Report Third Quarter 2022 Financial Results and Business Updates on November 9, 2022 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 con...
Minerva Neurosciences Receives Refusal to File Letter from FDA for its...
Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia BURLINGTON, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- (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 i...
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