{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-217810","form_type":"8-K","ticker":"ORGO","cik":"0001661181","company_name":"Organogenesis Holdings Inc.","filed_at":"2025-09-25T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.586130+00:00","generated_at":"2026-05-17T05:40:23.566615+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Organogenesis second Phase 3 ReNu knee OA trial misses primary endpoint; pre-BLA meeting planned","bullets":["Second Phase 3 (n=594) did not meet primary endpoint: WOMAC pain reduction difference -0.5 favoring ReNu (p=0.0393 vs target p=0.023).","ReNu showed numerical improvement in baseline pain reduction vs first Phase 3 (-6.9 vs -6.0); safety profile favorable.","Statistically significant maintenance of function (p<0.0001) reported in second study.","Company to request pre-BLA meeting with FDA by end of October 2025 to discuss combined efficacy from both Phase 3 trials.","First Phase 3 met primary endpoint (difference -0.7, p=0.0177); ReNu has FDA RMAT designation."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-217810","json":"https://secwatch.observer/filing/0001193125-25-217810.json","markdown":"https://secwatch.observer/filing/0001193125-25-217810.md","text":"https://secwatch.observer/filing/0001193125-25-217810.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1661181/000119312525217810/0001193125-25-217810-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1661181/000119312525217810/d870311d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T05:40:23.566615+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"}