---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-012944"
form_type: "8-K"
ticker: "GRCE"
cik: "0001444192"
company_name: "Grace Therapeutics, Inc."
filed_at: "2025-04-09T23:59:59+00:00"
generated_at: "2026-05-23T18:12:53.711090+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Grace Therapeutics announces FDA alignment supporting GTx-104 NDA submission; submission expected Q2 2025

## Summary
- Primary endpoint met: 19% reduction in clinically significant hypotension (28% GTx-104 vs 35% oral nimodipine).
- 54% of GTx-104 patients had relative dose intensity ≥95% vs 8% on oral nimodipine.
- 29% more patients had favorable functional outcomes at 90 days with GTx-104.
- 8 deaths on GTx-104 vs 4 on oral; none determined drug-related.
- NDA submission for GTx-104 anticipated in Q2 2025.

## SEC filing metadata
- accession: 0001140361-25-012944
- form_type: 8-K
- ticker: GRCE
- cik: 0001444192
- company_name: Grace Therapeutics, Inc.
- filed_at: 2025-04-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1444192/000114036125012944/0001140361-25-012944-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1444192/000114036125012944/ef20047157_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-012944
- JSON: https://secwatch.observer/filing/0001140361-25-012944.json
- Plain text: https://secwatch.observer/filing/0001140361-25-012944.txt

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