{"schema_version":"secwatch.filing_event.v1","accession":"0001178670-25-000038","form_type":"8-K","ticker":"ALNY","cik":"0001178670","company_name":"ALNYLAM PHARMACEUTICALS, INC.","filed_at":"2025-03-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:03.096382+00:00","generated_at":"2026-05-24T08:30:37.857319+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Alnylam gets FDA approval for AMVUTTRA in ATTR-CM, first RNAi therapy for cardiomyopathy","bullets":["FDA approved AMVUTTRA for ATTR-CM to reduce cardiovascular mortality, hospitalizations, and urgent heart failure visits.","HELIOS-B trial showed 28% risk reduction in all-cause mortality + recurrent CV events; 36% mortality reduction through 42 months overall.","First and only FDA-approved therapy covering both ATTR-CM and hATTR-PN manifestations in adults.","About 150K US patients affected; Alnylam expects $0 out-of-pocket cost for majority under Alnylam Assist program.","Marketing applications under review by EMA, ANVISA, PMDA; further global submissions planned in 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001178670-25-000038","json":"https://secwatch.observer/filing/0001178670-25-000038.json","markdown":"https://secwatch.observer/filing/0001178670-25-000038.md","text":"https://secwatch.observer/filing/0001178670-25-000038.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1178670/000117867025000038/0001178670-25-000038-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1178670/000117867025000038/alny-20250320.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T08:30:37.857319+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"}