02/03/2026 | Press release | Distributed by Public on 02/03/2026 08:00
| Item 7.01. |
Regulation FD Disclosure. |
As previously announced, Minerva Neurosciences, Inc. (the "Company") is hosting a virtual key opinion leader ("KOL") event on Tuesday, February 3, 2026 at 10:30 a.m. Eastern Time. The presentation to be used during the event will be made available on the Company's investor relations website at https://ir.minervaneurosciences.com/.
The contents of the Company's website referenced in this Current Report on Form 8-Kare not incorporated into this Current Report on Form 8-K.The Company routinely uses its investor relations website (https://ir.minervaneurosciences.com/) to post presentations to investors and other important information, including information that may be material. Accordingly, the Company encourages investors and others interested in the Company to review the information it makes public on its investor relations website.
The information in Item 7.01 of this Current Report on Form 8-Kis intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filling.
| Item 8.01. |
Other Events. |
At the KOL event, the Company will provide additional details regarding its proposed confirmatory Phase 3 trial of roluperidone for the treatment of negative symptoms in schizophrenia. Subject to ongoing feedback from the U.S. Food and Drug Administration, the trial is currently expected to be initiated, including first patient screened, in the second quarter of 2026. The trial is designed to enroll 380 patients, randomized on a 1:1 basis to receive either placebo or a double-blinded single daily 64 mg dose of roluperidone. The primary efficacy endpoint is expected to be the change from baseline in the PANSS Marder negative symptoms factor score (NSFS) at 12 weeks. Following the initial 12-week treatment period, patients are expected to enter a 40-week relapse assessment phase, during which patients will crossover to receive either a daily 64 mg dose of roluperidone or antipsychotics. The Company expects topline efficacy results in the second half of 2027 and relapse assessment data in the second half of 2028.