Minerva Neurosciences Secures $200 Million Financing to Drive Roluperidone Through Phase 3 Trial for Schizophrenia
Landmark Investment Targets Unmet Medical Need in Schizophrenia Treatment
Minerva Neurosciences (NASDAQ:NERV) announced it has secured a financing deal worth up to $200 million, fueling the advancement of roluperidone for treating the negative symptoms in patients with schizophrenia. This funding, which is structured through a mix of upfront investment, warrant tranches, and milestone-driven payments, comes as the company aligns with the FDA on the confirmatory Phase 3 trial design and sets its sights on resubmitting its New Drug Application (NDA) and preparing for potential U.S. commercial launch if approved.
Financing Details Position Minerva for Robust Clinical Progress
The financial agreement consists of $80 million in immediate capital from Series A Convertible Preferred Stock, with an additional $80 million available upon exercise of Tranche A warrants. A further $40 million may be unlocked through Tranche B warrants, subject to the successful achievement of clinical milestones. This comprehensive funding package, led by Vivo Capital and joined by notable healthcare investors such as Janus Henderson and Farallon Capital, is designed to carry Minerva through the entire Phase 3 trial and NDA resubmission process, including potential scaling of the trial.
| Funding Component | Amount (USD, Millions) | Condition |
|---|---|---|
| Initial Upfront (Series A Convertible Preferred Stock) | 80 | At closing (expected October 23, 2025) |
| Tranche A Warrants | 80 | Exercisable upon primary endpoint achievement |
| Tranche B Warrants | 40 | Milestone-driven or 3 years from issue |
| Total Potential Funding | 200 | - |
Clinical Development: Confirmatory Phase 3 Trial Backed by FDA Alignment
The confirmatory Phase 3 trial for roluperidone builds on previous studies and will enroll patients diagnosed with schizophrenia exhibiting stable negative and positive symptoms for at least six months prior to participation. The FDA has agreed that a 64 mg dose can be studied as monotherapy, mirroring prior Minerva trials. The trial’s primary efficacy endpoint is the change in PANSS Marder negative symptoms factor score at 12 weeks compared to placebo.
| Key Trial Details | Design / Outcome |
|---|---|
| Primary Endpoint | Change in PANSS negative symptoms factor at 12 weeks |
| Dose | 64 mg (monotherapy) |
| Randomization | 1:1, Double-blind, Placebo-controlled |
| U.S. Patient Participation | Targeting 25-30% of enrollees |
| Observation Duration | At least 52 weeks for relapse assessment |
Corporate Strengthening: Enhanced Board Expertise for Trial Execution
As part of the financing agreement, up to three new directors with deep experience in schizophrenia clinical trials will join Minerva's board, offering operational expertise as the Phase 3 trial progresses. A Scientific Advisory Board will also be established to provide strategic oversight and ensure clinical rigor.
Addressing a Major Unmet Need in Mental Health
Negative symptoms of schizophrenia—including blunted affect, lack of motivation, and social withdrawal—are not effectively treated by current antipsychotics and have a significant impact on patient quality of life. Despite millions affected, no therapies are FDA-approved specifically for these symptoms. If roluperidone demonstrates success, it could represent a much-needed breakthrough in psychiatric care, potentially changing the treatment paradigm for a population facing profound challenges.
What to Watch: Milestones and Commercialization Prospects
With a well-funded Phase 3 trial, clear regulatory guidance, and an expanded board of experts, Minerva is well-positioned for the next chapter. Investors and clinicians alike will be monitoring trial progress, FDA interactions, and potential approval timelines as key inflection points that could shape the future for roluperidone and for patients with schizophrenia struggling with negative symptoms.
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