---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-287430"
form_type: "8-K"
ticker: "NERV"
cik: "0001598646"
company_name: "Minerva Neurosciences, Inc."
filed_at: "2021-09-30T23:59:59+00:00"
generated_at: "2026-06-29T00:23:52.068258+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Minerva's roluperidone bioequivalence study meets all PK objectives; pre-NDA meeting planned

## Summary
- Study showed bioequivalence in AUC_inf between Phase 2b, Phase 3, and planned commercial formulations.
- C_max reduced substantially in reformulated Phase 3 and commercial tablets vs Phase 2b formulation.
- Commercial formulation bioequivalent with or without food; 45 of 48 subjects completed study.
- Company to request pre-NDA meeting with FDA for roluperidone for negative symptoms of schizophrenia.
- No approved treatments in US for negative symptoms of schizophrenia; roluperidone is potential first-in-class.

## SEC filing metadata
- accession: 0001193125-21-287430
- form_type: 8-K
- ticker: NERV
- cik: 0001598646
- company_name: Minerva Neurosciences, Inc.
- filed_at: 2021-09-30T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1598646/000119312521287430/0001193125-21-287430-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1598646/000119312521287430/d218690d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-287430
- JSON: https://secwatch.observer/filing/0001193125-21-287430.json
- Plain text: https://secwatch.observer/filing/0001193125-21-287430.txt

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