{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-012944","form_type":"8-K","ticker":"GRCE","cik":"0001444192","company_name":"Grace Therapeutics, Inc.","filed_at":"2025-04-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.314880+00:00","generated_at":"2026-05-23T18:12:53.711090+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":"Grace Therapeutics announces FDA alignment supporting GTx-104 NDA submission; submission expected Q2 2025","bullets":["Primary endpoint met: 19% reduction in clinically significant hypotension (28% GTx-104 vs 35% oral nimodipine).","54% of GTx-104 patients had relative dose intensity ≥95% vs 8% on oral nimodipine.","29% more patients had favorable functional outcomes at 90 days with GTx-104.","8 deaths on GTx-104 vs 4 on oral; none determined drug-related.","NDA submission for GTx-104 anticipated in Q2 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-012944","json":"https://secwatch.observer/filing/0001140361-25-012944.json","markdown":"https://secwatch.observer/filing/0001140361-25-012944.md","text":"https://secwatch.observer/filing/0001140361-25-012944.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1444192/000114036125012944/0001140361-25-012944-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1444192/000114036125012944/ef20047157_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T18:12:53.711090+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"}