{"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","discovered_at":"2026-05-14T18:03:18.449010+00:00","generated_at":"2026-06-01T00:58:49.457891+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Acasti achieves >50% enrollment in pivotal Phase 3 STRIVE-ON safety trial for GTX-104","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-078447","json":"https://secwatch.observer/filing/0000950170-24-078447.json","markdown":"https://secwatch.observer/filing/0000950170-24-078447.md","text":"https://secwatch.observer/filing/0000950170-24-078447.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T00:58:49.457891+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}