secwatch.observer — SEC 8-K summary
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Issuer:     Grace Therapeutics, Inc. (GRCE)
CIK:        0001444192
Form:       8-K
Filed at:   2023-07-05T23:59:59+00:00
Accession:  0000950170-23-031612
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1444192/000095017023031612/0000950170-23-031612-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1444192/000095017023031612/acst-20230705.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-031612

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