{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-021801","form_type":"8-K","ticker":"RYTM","cik":"0001649904","company_name":"RHYTHM PHARMACEUTICALS, INC.","filed_at":"2026-03-02T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.756017+00:00","generated_at":"2026-05-15T22:40:36.804057+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Rhythm reports additional positive Phase 3 TRANSCEND data for setmelanotide in hypothalamic obesity","bullets":["Placebo-adjusted BMI reduction of 18.8% (N=142); primary endpoint met with -16.4% BMI change on setmelanotide vs +2.4% on placebo (p<0.0001).","In patients aged 12+ (n=98), setmelanotide group showed 2.5-point reduction in weekly average most hunger score vs 1.3-point for placebo (p=0.0015).","sNDA under FDA review with PDUFA goal date of March 20, 2026; company submits final data package on March 2, 2026.","EMA reviewing Type II variation; CHMP opinion expected Q2 2026, potential EU marketing auth in H2 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-021801","json":"https://secwatch.observer/filing/0001104659-26-021801.json","markdown":"https://secwatch.observer/filing/0001104659-26-021801.md","text":"https://secwatch.observer/filing/0001104659-26-021801.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649904/000110465926021801/0001104659-26-021801-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649904/000110465926021801/tm267699d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T22:40:36.804057+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"}