secwatch.observer — SEC 8-K summary
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Issuer:     Grace Therapeutics, Inc. (GRCE)
CIK:        0001444192
Form:       8-K
Filed at:   2024-06-27T23:59:59+00:00
Accession:  0000950170-24-078447
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1444192/000095017024078447/0000950170-24-078447-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1444192/000095017024078447/acst-20240627.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-078447

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer