{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-24-114101","form_type":"8-K","ticker":"OGN","cik":"0001821825","company_name":"Organon & Co.","filed_at":"2024-11-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:09.835181+00:00","generated_at":"2026-05-30T05:27:09.809001+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"FDA extends VTAMA sNDA review for atopic dermatitis to March 12, 2025","bullets":["FDA extended target action date by 3 months to March 12, 2025; original date was December 12, 2024.","FDA requested final datasets and clinical study report from long-term extension study, deemed a major amendment.","No concerns raised regarding safety, efficacy, or approvability of VTAMA for atopic dermatitis.","Organon expects VTAMA full-year 2025 revenue of ~$125M; impact of ~75 bps headwind to Adjusted EBITDA margin.","Updated guidance provided as a supplement to prior Q3 2024 earnings call commentary."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-24-114101","json":"https://secwatch.observer/filing/0001104659-24-114101.json","markdown":"https://secwatch.observer/filing/0001104659-24-114101.md","text":"https://secwatch.observer/filing/0001104659-24-114101.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1821825/000110465924114101/0001104659-24-114101-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1821825/000110465924114101/tm2427489d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-30T05:27:09.809001+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"}