---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-313129"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2022-12-28T23:59:59+00:00"
generated_at: "2026-06-20T22:27:20.440103+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA upholds refusal to file Minerva's NDA for roluperidone for schizophrenia negative symptoms

## Summary
- FDA confirmed refusal-to-file letter dated Oct 14, 2022 remains in effect after Type A meeting on Nov 30, 2022.
- NDA for roluperidone for treatment of negative symptoms in schizophrenia denied filing by FDA.
- Company will continue to work with FDA and assess next steps for roluperidone.

## SEC filing metadata
- accession: 0001193125-22-313129
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2022-12-28T23:59:59+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/1598646/000119312522313129/0001193125-22-313129-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312522313129/d441264d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-313129
- JSON: https://secwatch.observer/filing/0001193125-22-313129.json
- Plain text: https://secwatch.observer/filing/0001193125-22-313129.txt

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