---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-056251"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2022-02-28T23:59:59+00:00"
generated_at: "2026-06-27T03:38:49.815749+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Phase 3 roluperidone results published; primary endpoint missed significance in ITT

## Summary
- Trial published in Schizophrenia Bulletin for roluperidone to treat negative symptoms in schizophrenia.
- Primary endpoint NSFS missed statistical significance in ITT (p≤0.064) but hit in m-ITT (p≤0.044).
- Secondary endpoint PSP total score statistically significant for 64 mg vs placebo (ITT p≤0.021).
- FDA denied pre-NDA meeting in Nov 2021; Type C meeting scheduled; NDA submission planned H1 2022.

## SEC filing metadata
- accession: 0001193125-22-056251
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2022-02-28T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1598646/000119312522056251/0001193125-22-056251-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312522056251/d321129d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-056251
- JSON: https://secwatch.observer/filing/0001193125-22-056251.json
- Plain text: https://secwatch.observer/filing/0001193125-22-056251.txt

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