---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-023557"
form_type: "8-K"
ticker: "GRCE"
cik: "0001444192"
company_name: "Grace Therapeutics, Inc."
filed_at: "2025-06-25T23:59:59+00:00"
generated_at: "2026-05-18T19:13:45.471583+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Grace Therapeutics submits NDA for GTx-104 in aSAH; Phase 3 data positive

## Summary
- NDA for GTx-104 (injectable nimodipine) submitted to FDA for aneurysmal subarachnoid hemorrhage.
- Phase 3 STRIVE-ON trial met primary endpoint: 19% reduction in clinically significant hypotension vs oral nimodipine.
- 54% of GTx-104 patients had relative dose intensity ≥95% vs 8% on oral; 29% more favorable functional outcomes at 90 days.
- Submission may trigger exercise of warrants issued in Sept 2023, yielding up to $7.6M gross proceeds.
- GTx-104 has FDA Orphan Drug Designation, providing 7 years U.S. exclusivity if approved.

## SEC filing metadata
- accession: 0001140361-25-023557
- form_type: 8-K
- ticker: GRCE
- cik: 0001444192
- company_name: Grace Therapeutics, Inc.
- filed_at: 2025-06-25T23:59:59+00:00
- event_type: regulatory
- 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/1444192/000114036125023557/0001140361-25-023557-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1444192/000114036125023557/ef20051001_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-023557
- JSON: https://secwatch.observer/filing/0001140361-25-023557.json
- Plain text: https://secwatch.observer/filing/0001140361-25-023557.txt

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