secwatch.observer — SEC 8-K summary
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Issuer:     Grace Therapeutics, Inc. (GRCE)
CIK:        0001444192
Form:       8-K
Filed at:   2024-09-25T23:59:59+00:00
Accession:  0001140361-24-041832
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Acasti Pharma completes enrollment in pivotal Phase 3 STRIVE-ON trial of GTX-104 for aSAH
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- Patient enrollment completed for GTX-104 (injectable nimodipine) vs oral nimodipine in 100 patients across ~25 U.S. hospitals.
- Data readout from STRIVE-ON safety trial expected early calendar 2025; primary endpoint is comparative adverse events including hypotension.
- NDA submission to FDA on track for first half of 2025, consistent with timeline.
- CEO Prashant Kohli says milestone achieved ahead of original expectations; believes GTX-104 may transform aSAH standard of care.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1444192/000114036124041832/0001140361-24-041832-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1444192/000114036124041832/ef20036277_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-24-041832

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