{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-051504","form_type":"8-K","ticker":"IRON","cik":"0001816736","company_name":"Disc Medicine, Inc.","filed_at":"2026-02-13T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.283602+00:00","generated_at":"2026-05-16T02:48:39.387221+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA issues Complete Response Letter for Disc Medicine's bitopertin NDA for EPP; approval delayed","bullets":["FDA acknowledged bitopertin significantly lowers PPIX but found insufficient evidence that PPIX change predicts clinical benefit.","Phase 3 APOLLO study ongoing; topline data expected Q4 2026; could support traditional approval.","Company plans Type A meeting with FDA; expects resubmission and decision by mid-2027 if APOLLO successful.","Disc Medicine has approximately $791M cash (unaudited, Dec 31, 2025) with runway into 2029.","CRL delays potential approval; stock likely to face negative pressure."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-051504","json":"https://secwatch.observer/filing/0001193125-26-051504.json","markdown":"https://secwatch.observer/filing/0001193125-26-051504.md","text":"https://secwatch.observer/filing/0001193125-26-051504.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1816736/000119312526051504/0001193125-26-051504-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1816736/000119312526051504/iron-20260213.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T02:48:39.387221+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"}