secwatch.observer — SEC 8-K summary
======================================

Issuer:     Minerva Neurosciences, Inc. (NERV)
CIK:        0001598646
Form:       8-K
Filed at:   2026-02-03T23:59:59+00:00
Accession:  0001193125-26-034538
Event type: other_material
Sentiment:  neutral
Materiality: 0.70
Item codes: 7.01, 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1598646/000119312526034538/0001193125-26-034538-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1598646/000119312526034538/d896733d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-034538

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer