{"schema_version":"secwatch.filing_event.v1","accession":"0001824293-25-000160","form_type":"8-K","ticker":"GRI","cik":"0001824293","company_name":"GRI Bio, Inc.","filed_at":"2025-12-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.636122+00:00","generated_at":"2026-05-16T14:03:38.076405+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"GRI Bio reports positive Phase 2a data for GRI-0621 in IPF; primary endpoint met","bullets":["Phase 2a trial (35 IPF subjects, 2:1 randomization) met primary safety endpoint; GRI-0621 well tolerated over 12 weeks with no treatment-related SAEs.","Placebo-adjusted FVC increased 99 ml (all treated) and 139 ml (on top of standard of care); 39% of treated had FVC gain vs 80% decline on placebo.","Serum biomarkers showed anti-fibrotic effect (decreased fibrosis markers, increased resolution markers) and alveolar basement membrane repair signals.","Adverse events were grade 2 (17%) or grade 3 (4%); common: dry skin, dry lips, muscle pain; no cough or GI increase vs placebo.","80% of subjects on background pirfenidone/nintedanib; no changes in liver enzymes, triglycerides or cholesterol observed."],"urls":{"canonical":"https://secwatch.observer/filing/0001824293-25-000160","json":"https://secwatch.observer/filing/0001824293-25-000160.json","markdown":"https://secwatch.observer/filing/0001824293-25-000160.md","text":"https://secwatch.observer/filing/0001824293-25-000160.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1824293/000182429325000160/0001824293-25-000160-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1824293/000182429325000160/val-20251208.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:03:38.076405+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"}