---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-226016"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2022-08-22T23:59:59+00:00"
generated_at: "2026-06-23T22:17:16.388760+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Minerva submits NDA to FDA for roluperidone (64 mg) to treat negative symptoms of schizophrenia

## Summary
- NDA supported by two late-stage studies (MIN-101C03 and MIN-101C07) in patients with moderate to severe negative symptoms.
- Study MIN-101C03 met primary endpoint: statistically significant reduction in negative symptoms (p≤0.0036) at 12 weeks.
- Study MIN-101C07 marginally missed primary ITT analysis (p≤0.064) but showed significance in mITT (p≤0.044) and on key secondary PSP scale.
- Company seeks approval for 64 mg dose; no approved therapies currently exist in the US for negative symptoms of schizophrenia.
- Additional data provided following March 2022 Type C meeting with FDA to address impact on antipsychotics, comparability of patients, and statistical evidence.

## SEC filing metadata
- accession: 0001193125-22-226016
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2022-08-22T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1598646/000119312522226016/0001193125-22-226016-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312522226016/d364410d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-226016
- JSON: https://secwatch.observer/filing/0001193125-22-226016.json
- Plain text: https://secwatch.observer/filing/0001193125-22-226016.txt

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