{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-123990","form_type":"8-K","ticker":"RYTM","cik":"0001649904","company_name":"RHYTHM PHARMACEUTICALS, INC.","filed_at":"2023-12-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.936366+00:00","generated_at":"2026-06-07T17:08:36.776529+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Rhythm Pharma reports positive Phase 3 setmelanotide data in young children; files for EU approval","bullets":["Phase 3 pediatrics trial: 83.3% (10/12) achieved BMI-Z score reduction ≥0.2 at 52 weeks; mean BMI reduction 18.4%.","Submitted Type II variation to EMA for setmelanotide in children 2 to <6 with BBS/POMC/PCSK1/LEPR deficiency; sNDA to FDA planned H1 2024.","Phase 2 DAYBREAK trial: response rates by genotype ranged 25%–56.3%; 49 patients randomized into Stage 2 placebo-controlled withdrawal; data expected H2 2024.","IND submitted for RM-718 (weekly MC4R agonist); Phase 1 trials including hypothalamic obesity planned H1 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-123990","json":"https://secwatch.observer/filing/0001104659-23-123990.json","markdown":"https://secwatch.observer/filing/0001104659-23-123990.md","text":"https://secwatch.observer/filing/0001104659-23-123990.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649904/000110465923123990/0001104659-23-123990-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649904/000110465923123990/tm2332304d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T17:08:36.776529+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"}