---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-047110"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2024-02-27T23:59:59+00:00"
generated_at: "2026-06-05T11:55:57.015442+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 1.0
calibrated_materiality_score: 1.0
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for roluperidone; NDA not approved

## Summary
- FDA cited single positive study insufficient; requires at least one additional positive well-controlled trial.
- CRL also demands data on co-administration with antipsychotics and clinically meaningful change.
- Safety database inadequate: too few subjects on 64 mg for 12+ months.
- Minerva will request a meeting with FDA to discuss path forward; CEO expresses disappointment.
- Roluperidone was targeting negative symptoms of schizophrenia, an unmet need.

## SEC filing metadata
- accession: 0001193125-24-047110
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2024-02-27T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 1.0
- calibrated_materiality_score: 1.0
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1598646/000119312524047110/0001193125-24-047110-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312524047110/d795805d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-047110
- JSON: https://secwatch.observer/filing/0001193125-24-047110.json
- Plain text: https://secwatch.observer/filing/0001193125-24-047110.txt

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