---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-031612"
form_type: "8-K"
ticker: "GRCE"
cik: "0001444192"
company_name: "Grace Therapeutics, Inc."
filed_at: "2023-07-05T23:59:59+00:00"
generated_at: "2026-06-13T12:38:09.079008+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Acasti aligns with FDA on GTX-104 Phase 3 safety trial protocol; STRIVE-ON to start Q4 2023

## Summary
- FDA confirmed alignment on STRIVE-ON trial design and dosing regimen for GTX-104 in aSAH patients.
- STRIVE-ON will enroll ~100 patients at ~25 US hospitals; primary endpoint is safety vs oral nimodipine.
- GTX-104 administered to >150 healthy volunteers with comparable safety to oral nimodipine to date.
- Cash runway projected through potential NDA submission in H1 2025.
- First patient dosing expected in Q4 2023; NDA submission targeted for first half of 2025.

## SEC filing metadata
- accession: 0000950170-23-031612
- form_type: 8-K
- ticker: GRCE
- cik: 0001444192
- company_name: Grace Therapeutics, Inc.
- filed_at: 2023-07-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- 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/1444192/000095017023031612/0000950170-23-031612-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1444192/000095017023031612/acst-20230705.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-031612
- JSON: https://secwatch.observer/filing/0000950170-23-031612.json
- Plain text: https://secwatch.observer/filing/0000950170-23-031612.txt

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