---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-078447"
form_type: "8-K"
ticker: "GRCE"
cik: "0001444192"
company_name: "Grace Therapeutics, Inc."
filed_at: "2024-06-27T23:59:59+00:00"
generated_at: "2026-06-01T00:58:49.457891+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Acasti achieves >50% enrollment in pivotal Phase 3 STRIVE-ON safety trial for GTX-104

## Summary
- Phase 3 STRIVE-ON trial of GTX-104 (IV nimodipine) for aneurysmal subarachnoid hemorrhage (aSAH) surpassed 50% patient enrollment.
- Trial design: 100 patients, open-label, randomized 1:1 vs oral nimodipine; primary endpoint is comparative safety (hypotension).
- Enrollment began Oct 2023; completion anticipated late 2024–early 2025; NDA submission on track for 1H 2025.
- GTX-104 is designed for IV infusion in ICU, avoiding nasogastric tube in unconscious/dysphagic aSAH patients.
- US addressable market for GTX-104 estimated at ~$300M per market research.

## SEC filing metadata
- accession: 0000950170-24-078447
- form_type: 8-K
- ticker: GRCE
- cik: 0001444192
- company_name: Grace Therapeutics, Inc.
- filed_at: 2024-06-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1444192/000095017024078447/0000950170-24-078447-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1444192/000095017024078447/acst-20240627.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-078447
- JSON: https://secwatch.observer/filing/0000950170-24-078447.json
- Plain text: https://secwatch.observer/filing/0000950170-24-078447.txt

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