{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-032847","form_type":"8-K","ticker":"GRCE","cik":"0001444192","company_name":"Grace Therapeutics, Inc.","filed_at":"2025-08-27T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.006508+00:00","generated_at":"2026-05-17T09:40:50.175544+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts Grace Therapeutics' NDA for GTx-104; PDUFA date set for April 23, 2026","bullets":["FDA accepted NDA for GTx-104 (injectable nimodipine) for aSAH treatment; PDUFA target April 23, 2026.","Acceptance triggers up to $7.6M in warrants exercisable at $3.003/share, expiring 60 days post-acceptance or Sept 25, 2028.","Phase 3 STRIVE-ON trial met primary endpoint: 19% reduction in clinically significant hypotension vs oral nimodipine (28% vs 35%).","GTx-104 showed 54% of patients had ≥95% relative dose intensity vs 8% for oral; 29% more favorable functional outcomes at 90 days.","Orphan Drug Designation provides 7-year US marketing exclusivity if approved."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-032847","json":"https://secwatch.observer/filing/0001140361-25-032847.json","markdown":"https://secwatch.observer/filing/0001140361-25-032847.md","text":"https://secwatch.observer/filing/0001140361-25-032847.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1444192/000114036125032847/0001140361-25-032847-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1444192/000114036125032847/ef20054617_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T09:40:50.175544+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"}