{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-034381","form_type":"8-K","ticker":"IRWD","cik":"0001446847","company_name":"IRONWOOD PHARMACEUTICALS INC","filed_at":"2025-04-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.320700+00:00","generated_at":"2026-05-23T15:25:13.132394+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA requires confirmatory Phase 3 trial for apraglutide; Ironwood explores strategic alternatives","bullets":["FDA feedback indicates a confirmatory Phase 3 trial is needed to seek approval of apraglutide for SBS-IF; company will work on design and regulatory path.","Pharmacokinetic analysis found exposure and dose in STARS Phase 3 trial were lower than planned due to dose preparation and administration.","Ironwood has engaged Goldman Sachs & Co. LLC to explore strategic alternatives to maximize stockholder value.","Long-term extension data: 27 apraglutide-dosed patients achieved enteral autonomy (no parenteral support); STARS data remains part of NDA package."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-034381","json":"https://secwatch.observer/filing/0001104659-25-034381.json","markdown":"https://secwatch.observer/filing/0001104659-25-034381.md","text":"https://secwatch.observer/filing/0001104659-25-034381.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1446847/000110465925034381/0001104659-25-034381-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1446847/000110465925034381/tm2512215d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T15:25:13.132394+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"}