---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-317782"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2021-11-03T23:59:59+00:00"
generated_at: "2026-06-28T14:02:29.065028+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA denies Minerva's pre-NDA meeting request for roluperidone, recommends Type C meeting

## Summary
- FDA denied pre-NDA meeting for roluperidone (negative symptoms of schizophrenia); recommends Type C guidance meeting instead.
- Minerva plans to request the Type C meeting; still targeting NDA submission in first half of 2022.
- No FDA-approved drugs exist in the U.S. for negative symptoms of schizophrenia.

## SEC filing metadata
- accession: 0001193125-21-317782
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2021-11-03T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1598646/000119312521317782/0001193125-21-317782-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312521317782/d193784d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-317782
- JSON: https://secwatch.observer/filing/0001193125-21-317782.json
- Plain text: https://secwatch.observer/filing/0001193125-21-317782.txt

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