---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-034538"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2026-02-03T23:59:59+00:00"
generated_at: "2026-05-16T05:19:51.966124+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-26-034538
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2026-02-03T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1598646/000119312526034538/0001193125-26-034538-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312526034538/d896733d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-034538
- JSON: https://secwatch.observer/filing/0001193125-26-034538.json
- Plain text: https://secwatch.observer/filing/0001193125-26-034538.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.