Minerva unveils Phase 3 trial design for roluperidone; planned start Q2 2026

Minerva Neurosciences, Inc.

Phase 3 trial to enroll 380 patients with negative symptoms of schizophrenia; 1:1 randomization to placebo or 64 mg roluperidone.
Primary endpoint: change from baseline in PANSS Marder negative symptoms factor score (NSFS) at 12 weeks.
After 12 weeks, patients enter 40-week relapse assessment phase; crossover to roluperidone or antipsychotics.
Topline efficacy results expected H2 2027; relapse assessment data expected H2 2028.
Trial initiation (first patient screened) subject to FDA feedback, targeted Q2 2026.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.