NERV - Earnings announcements

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

WALTHAM, Mass., Dec. 01, 2020 (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 has received official meeting minutes from the November 10, 2020 Type C meeting with the U.S. Food and Drug Administration (FDA) regarding development of roluperidone for treatment of negative symptoms in schizophrenia. The objective of this meeting was to obtain FDA input regarding the roluperidone data package and its readiness to support a New Drug Application (NDA) submission. The two main topics addressed during the meeting were: 1.   Re