{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-424649","form_type":"8-K","ticker":"IRON","cik":"0001816736","company_name":"Disc Medicine, Inc.","filed_at":"2026-10-19T11:08:08+00:00","discovered_at":"2026-10-19T11:10:02.542411+00:00","generated_at":"2026-10-19T11:10:08.309383+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.92,"calibrated_materiality_score":0.92,"confidence":"high","headline":"Disc Medicine's bitopertin meets all Phase 3 APOLLO endpoints in EPP; NDA resubmission planned for end-2026","bullets":["Phase 3 APOLLO enrolled 183 EPP/XLP patients aged 12+ across US, Canada, Europe, Australia; randomized 1:1 to 60 mg oral bitopertin or placebo for 6 months.","Co-primary endpoints met: whole-blood metal-free PPIX fell 41.4% vs placebo (p<0.0001); average monthly pain-free light time rose 12.2 hours in month 6 (p=0.0010).","All secondary endpoints significant: lower phototoxic reaction incidence (p<0.0001), more cumulative pain-free light time (p<0.0001), improved PGIC and PGIS scores (p<0.0001).","Dizziness was most common TEAE at 50%, mild/moderate and generally transient; no TEAEs above Grade 3 and no new safety signals.","Disc plans NDA resubmission to FDA by end-2026, with FDA decision anticipated by mid-2027; webcast Oct 19, 2026 at 8:00am ET."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-424649","json":"https://secwatch.observer/filing/0001193125-26-424649.json","markdown":"https://secwatch.observer/filing/0001193125-26-424649.md","text":"https://secwatch.observer/filing/0001193125-26-424649.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1816736/000119312526424649/0001193125-26-424649-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1816736/000119312526424649/d156263d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-19T11:10:08.309383+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"}