---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-032847"
form_type: "8-K"
ticker: "GRCE"
cik: "0001444192"
company_name: "Grace Therapeutics, Inc."
filed_at: "2025-08-27T23:59:59+00:00"
generated_at: "2026-05-17T09:40:50.175544+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Grace Therapeutics' NDA for GTx-104; PDUFA date set for April 23, 2026

## Summary
- FDA accepted NDA for GTx-104 (injectable nimodipine) for aSAH treatment; PDUFA target April 23, 2026.
- Acceptance triggers up to $7.6M in warrants exercisable at $3.003/share, expiring 60 days post-acceptance or Sept 25, 2028.
- Phase 3 STRIVE-ON trial met primary endpoint: 19% reduction in clinically significant hypotension vs oral nimodipine (28% vs 35%).
- GTx-104 showed 54% of patients had ≥95% relative dose intensity vs 8% for oral; 29% more favorable functional outcomes at 90 days.
- Orphan Drug Designation provides 7-year US marketing exclusivity if approved.

## SEC filing metadata
- accession: 0001140361-25-032847
- form_type: 8-K
- ticker: GRCE
- cik: 0001444192
- company_name: Grace Therapeutics, Inc.
- filed_at: 2025-08-27T23:59:59+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/1444192/000114036125032847/0001140361-25-032847-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1444192/000114036125032847/ef20054617_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-032847
- JSON: https://secwatch.observer/filing/0001140361-25-032847.json
- Plain text: https://secwatch.observer/filing/0001140361-25-032847.txt

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