---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-098270"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2022-04-07T23:59:59+00:00"
generated_at: "2026-06-26T08:49:23.830010+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA says Phase 3 study for roluperidone remains negative; additional data needed

## Summary
- FDA stated the Phase 3 study is negative under the Hochberg procedure; both 32 mg and 64 mg doses must be significant.
- Excluding a site with data integrity issues gave nominal p=0.044 for 64 mg dose, but FDA still deems study negative.
- Division raised concerns about monotherapy use, patient identification, and lack of data on coadministration with antipsychotics.
- FDA suggested additional data could address concerns; Minerva may begin data collection in parallel with NDA preparations.
- Minerva still believes it has two adequate studies and targets NDA submission in summer 2022; webcast April 13.

## SEC filing metadata
- accession: 0001193125-22-098270
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2022-04-07T23:59:59+00:00
- event_type: other_material
- 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/1598646/000119312522098270/0001193125-22-098270-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312522098270/d323194d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-098270
- JSON: https://secwatch.observer/filing/0001193125-22-098270.json
- Plain text: https://secwatch.observer/filing/0001193125-22-098270.txt

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