NERV

Confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia initiated and first patient screened Previous open label trial data presented at SIRS 2026 showed no safety or drug–drug interaction concerns with roluperidone and olanzapine Roluperidone remains the only late-stage drug candidate for this high-need population BURLINGTON, Mass., May 05, 2026 (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 financial and business updates for the first quarter ended March 31, 2026. Business Updates Roluperidone - potentially the First Treatment for Negative Symptoms of Schizophrenia Minerva initiated its global confirmatory Phase 3 clinical trial of roluperidone for the treatment of negative symptoms of schizophrenia during the first quarter of 2026 with efficacy topline data expected 2H 2027. The Company screened the first patient in March 2026, marking an important operational milestone for the program. The Phase 3 trial will enroll approximately 380 patients across roughly 40 clinical sites worldwide, including the United States (US) and multiple European countries. This confirmatory Phase 3 trial follows productive discussions with the FDA on the overall design and efficacy assessments and builds directly on Minerva’s clinical success in the prior pivotal Phase 2b and Phase 3 trials (C03 and C07). The trial will evaluate roluperidone 64 mg versus placebo to confirm the effect of roluperidone on primary negative symptoms at 12 weeks. The trial will also evaluate on an informational basis the longer-term relapse rate of positive symptoms for roluperidone as compared with several commonly prescribed antipsychotic medications for an additional 40 weeks. See “About the Phase 3 MIN-101C19 Trial” below for more information. Roluperidone remains the only late-stage drug candidate for this high-need population. Scientific presentations - further supporting the roluperidone program and reinforcing real world applicability In March 2026, Minerva presented data from its open-label safety trial evaluating roluperidone co-administered with olanzapine at the Schizophrenia International Research Society (SIRS) 2026 Annual Congress. The data demonstrated no clinically meaningful safety concerns, no signifi...

BURLINGTON, Mass. (AP) — BURLINGTON, Mass. (AP) — Minerva Neurosciences Inc. (NERV) on Tuesday reported a loss of $125.4 million in its first quarter. The Burlington, Massachusetts-based company said it had a loss of $2.86 per share. Losses, adjusted for non-recurring costs, came to 17 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on NERV at https://www.zacks.com/ap/NERV

Initiation of confirmatory Phase 3 trial with roluperidone for negative symptoms of schizophrenia is planned for Q2 2026, with topline data anticipated in 2H 2027 BURLINGTON, Mass., March 11, 2026 (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 provided business updates and reported financial results for the fourth quarter and year ended December 31, 2025. Business Updates Strategic Financing On October 23, 2025, Minerva received $80.0 million in gross proceeds from a private placement, before deducting fees and other expenses. The financing included initial upfront funding of $80.0 million and up to an additional $80.0 million if all Tranche A warrants are exercised, subject to the terms and conditions specified therein. Additional proceeds of $40.0 million may be received if all Tranche B warrants are exercised by cash payment upon the achievement of the primary endpoint of Minerva’s Phase 3 confirmatory trial of roluperidone in schizophrenia at the 12-week efficacy endpoint expected in 2H 2027. “Strengthened by the recent financing and our general alignment with the U.S. Food and Drug Administration (“FDA”) on trial design, we are working towards initiation of the confirmatory Phase 3 trial with roluperidone for the treatment of negative symptoms of schizophrenia in the second quarter,” said Dr. Remy Luthringer, Chairman and CEO of Minerva Neurosciences. “With the $80 million upfront proceeds and the exercise proceeds from the Tranche A warrants, we anticipate sufficient funds to complete the Phase 3 trial and resubmission of the New Drug Application (“NDA”) ahead of the launch of roluperidone in the United States, if approved.” Roluperidone - Potentially the First Treatment for Negative Symptoms of Schizophrenia Roluperidone is the only investigational therapy, to date, to demonstrate significant and clinically meaningful improvements on the primary negative symptoms of schizophrenia. Minerva has achieved general alignment with FDA on the confirmatory Phase 3 trial design. The Phase 3 trial remains on track to initiate in the second quarter of 2026, with a trial design similar to Minerva's two previous studies. The first phase of the trial has a primary efficacy endpoint to evaluate the improvement in n...

BURLINGTON, Mass. (AP) — BURLINGTON, Mass. (AP) — Minerva Neurosciences Inc. (NERV) on Wednesday reported a loss of $283.7 million in its fourth quarter. On a per-share basis, the Burlington, Massachusetts-based company said it had a loss of $25.51. Losses, adjusted for non-recurring costs, came to 64 cents per share. For the year, the company reported a loss of $293.4 million, or $34.67 per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on NERV at https://www.zacks.com/ap/NERV

BURLINGTON, Mass., Nov. 05, 2025 (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 2025 ending September 30, 2025. Business Updates On October 23, 2025, the Company received $80 million in gross proceeds in a private placement, before deducting fees and other expenses. The financing includes an initial upfront funding of $80 million and up to an additional $80 million in gross proceeds if all Tranche A warrants are exercised, subject to the terms and conditions specified therein. Additional proceeds of $40 million may be received if all Tranche B warrants are exercised by cash payment upon the achievement of the primary endpoint of its Phase 3 confirmatory trial of roluperidone in schizophrenia at the 12-week timepoint. “Strengthened by the recent financing and our alignment with FDA on a confirmatory Phase 3 clinical trial, we are now on a path forward to advancing roluperidone for the treatment of negative symptoms of schizophrenia,” said Dr. Remy Luthringer, Chairman and CEO of Minerva Neurosciences. “While we anticipate increases in R&D, clinical and administrative expenses, we anticipate having sufficient funds for the Phase 3 study and resubmission of our NDA, and to prepare for a commercial launch of roluperidone in the US, if approved.” Third Quarter 2025 Financial Results Research and development (R&D) expense: For the three months ended September 30, 2025 and 2024, R&D expense was $0.9 million and $1.9 million, respectively. R&D expense was lower versus the prior year period primarily due to lower costs associated with our drug substance validation campaign, consultant fees, and lower compensation expenses. For the nine months ended September 30, 2025 and 2024, R&D expense was $3.6 million and $9.9 million, respectively. R&D expense was lower versus the prior year period primarily due to lower costs associated with our drug substance validation campaign, costs for the C18 study, consultant fees, and lower compensation expenses. General and administrative (G&A) expense: For the three months ended September 30, 2025 and 2024, G&A expense was $1.9 million and $2.5 million, respectively. G&A expense was lower versus the prior year...

BURLINGTON, Mass. (AP) — BURLINGTON, Mass. (AP) — Minerva Neurosciences Inc. (NERV) on Wednesday reported a loss of $2.7 million in its third quarter. The Burlington, Massachusetts-based company said it had a loss of 36 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on NERV at https://www.zacks.com/ap/NERV

BURLINGTON, Mass. (AP) — BURLINGTON, Mass. (AP) — Minerva Neurosciences Inc. (NERV) on Thursday reported a loss of $3.3 million in its second quarter. On a per-share basis, the Burlington, Massachusetts-based company said it had a loss of 43 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on NERV at https://www.zacks.com/ap/NERV

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 clinical trial to address the deficiencies cited in the CRL and resubmit the NDA. As in the two previous studies (C03 and C07), the required confirmatory clinical trial would include patients diagnosed with schizophrenia who present with impairing negative symptoms and stable positive symptoms. Patients would be selected based on stable positive symptoms and impairing negative symptoms for the six months prior to entering the trial. Minerva agreed with FDA that best efforts will be made to secure 25-30% of patients from USA (subject to competitive recruitment). The FDA has confirmed that roluperidone can be studied in monotherapy where patients would receive a double-blinded single daily 64 mg dose of roluperidone or placebo. The FDA has also confirmed that, the primary endpoint would be the change from Baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks of treatment with roluperidone compared to placebo. The FDA advised that, to support a monotherapy indication, it would be necessary to assess relapses on an observational basis for at least 52 weeks in patients treated in monotherapy with roluperidone, placebo or antipsychotics. The FDA has stated that it would consider a resubmission of the NDA that included a double-blind, placebo- or active-controlled trial of roluperidone with a duration of at least 52 weeks. The trial’s potential sole key secondary endpoint would be the comparison of the change from Baseline in the Personal and Social Performance scale total score (PSP) to Week 12, which is a scale to assess patients’ social functioning. The trial will also potentially measure the change from Baseline in Clinical Global Impression of Severity (CGI-S), chan...

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 (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia as first disclosed in the first quarter of 2024. First Quarter 2025 Financial Results Research and development (R&D) expense: For the three months ended March 31, 2025 and 2024, R&D expense was $1.4 million and $4.2 million, respectively. R&D expense was lower versus the prior year period primarily due to costs associated with the FDA’s review of our NDA for roluperidone, costs for the C18 study, and lower compensation expenses. General and administrative (G&A) expense: For both the three months ended March 31, 2025 and 2024, G&A expense was $2.5 million. Non-cash interest expense: For the three months ended March 31, 2025 and 2024, non-cash interest expense for the sale of future royalties was zero and $2.3 million, respectively. Non-cash interest expense was lower versus the prior year period due to revising our estimates for the timing and amount of future royalty payments to be received under the royalty arrangement. During the third quarter of 2024, we adjusted the carrying amount of our liability related to the sale of future royalties to the initial payment of $60 million. This adjustment resulted in the recognition of $26.6 million in other income during the third quarter of 2024, representing the amount of non-cash interest expense amortized through June 30, 2024. Net loss: Net loss was $3.8 million for the three months ended March 31, 2025, or a basic and diluted net loss per share of $0.50, as compared to net loss of $8.6 million for the three months ended March 31, 2024, or a basic and diluted net loss per share of $1.13. Cash Position: Cash, cash equivalents and restricted cash a...

BURLINGTON, Mass. (AP) — BURLINGTON, Mass. (AP) — Minerva Neurosciences Inc. (NERV) on Tuesday reported a loss of $3.8 million in its first quarter. On a per-share basis, the Burlington, Massachusetts-based company said it had a loss of 50 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on NERV at https://www.zacks.com/ap/NERV