---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-263403"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2022-10-17T23:59:59+00:00"
generated_at: "2026-06-23T03:20:01.463471+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Minerva Neurosciences receives FDA refusal to file for roluperidone NDA in schizophrenia negative symptoms

## Summary
- FDA issued Refusal to File letter for NDA of roluperidone for negative symptoms of schizophrenia.
- No approved therapies exist in US for negative symptoms of schizophrenia; company disappointed.
- Company intends to request a Type A meeting to discuss the refusal to file letter.
- Roluperidone is a clinical-stage therapy; NDA submission not accepted by FDA.

## SEC filing metadata
- accession: 0001193125-22-263403
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2022-10-17T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1598646/000119312522263403/0001193125-22-263403-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312522263403/d370453d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-263403
- JSON: https://secwatch.observer/filing/0001193125-22-263403.json
- Plain text: https://secwatch.observer/filing/0001193125-22-263403.txt

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