{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-016324","form_type":"8-K","ticker":"GRCE","cik":"0001444192","company_name":"Grace Therapeutics, Inc.","filed_at":"2026-04-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.298903+00:00","generated_at":"2026-05-15T04:30:06.547752+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA issues Complete Response Letter for Grace Therapeutics' GTx-104 NDA; cites CMC and non-clinical issues","bullets":["FDA CRL for GTx-104 (nimodipine IV) in aSAH; no additional clinical data requested.","Cited leachables data, non-clinical toxicology, and manufacturing deficiencies at CMO.","Company plans Type A meeting with FDA and intends to resubmit after resolving cited items.","STRIVE-ON trial met primary endpoint; 19% reduction in hypotension vs. oral nimodipine.","No deaths deemed drug-related; favorable functional outcomes and higher dose intensity observed."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-016324","json":"https://secwatch.observer/filing/0001140361-26-016324.json","markdown":"https://secwatch.observer/filing/0001140361-26-016324.md","text":"https://secwatch.observer/filing/0001140361-26-016324.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1444192/000114036126016324/0001140361-26-016324-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1444192/000114036126016324/ef20070593_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T04:30:06.547752+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"}