{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-009095","form_type":"8-K","ticker":"IRON","cik":"0001816736","company_name":"Disc Medicine, Inc.","filed_at":"2025-01-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:05.026218+00:00","generated_at":"2026-05-27T22:21:56.870875+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Disc Medicine aligns with FDA on bitopertin confirmatory trial design; NDA planned H2 2025","bullets":["Achieved FDA alignment on APOLLO post-marketing trial design for bitopertin in EPP and XLP.","Co-primary endpoints: monthly total sunlight time without pain and percent change in whole-blood PPIX.","Plans to submit NDA for accelerated approval in H2 2025 based on Phase 2 BEACON and AURORA data.","APOLLO trial to enroll ~150 patients aged 12+, randomized 1:1, 60 mg dose, double-blind placebo-controlled.","Trial initiation expected by mid-2025; enrollment underway by potential accelerated approval date."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-009095","json":"https://secwatch.observer/filing/0001193125-25-009095.json","markdown":"https://secwatch.observer/filing/0001193125-25-009095.md","text":"https://secwatch.observer/filing/0001193125-25-009095.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1816736/000119312525009095/0001193125-25-009095-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1816736/000119312525009095/d858127d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T22:21:56.870875+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"}