---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-351399"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2021-12-08T23:59:59+00:00"
generated_at: "2026-06-28T02:49:54.012563+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Roluperidone phase 3 trial: primary endpoint missed in ITT (p=0.064) but significant in mITT; PSP improved

## Summary
- NSFS (primary) for roluperidone 64mg vs placebo: p≤0.064 (ITT), p≤0.044 (mITT).
- PSP total score (key secondary) significantly improved for 64mg vs placebo: p≤0.021 (ITT), p≤0.017 (mITT).
- Relapse rate during open-label extension: 6% (64mg) and 9% (32mg) over one year.
- Trial enrolled 513 schizophrenia patients with moderate to severe negative symptoms; monotherapy design.
- Results presented at ACNP meeting December 2021.

## SEC filing metadata
- accession: 0001193125-21-351399
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2021-12-08T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1598646/000119312521351399/0001193125-21-351399-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312521351399/d74277d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-351399
- JSON: https://secwatch.observer/filing/0001193125-21-351399.json
- Plain text: https://secwatch.observer/filing/0001193125-21-351399.txt

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