{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-253084","form_type":"8-K","ticker":"ALNY","cik":"0001178670","company_name":"ALNYLAM PHARMACEUTICALS, INC.","filed_at":"2023-10-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.426961+00:00","generated_at":"2026-06-10T02:02:52.250662+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 rejects Alnylam's patisiran sNDA for ATTR cardiomyopathy; company abandons U.S. expansion","bullets":["FDA issued Complete Response Letter citing insufficient evidence of clinical meaningfulness for patisiran in cardiomyopathy of ATTR amyloidosis.","No safety, study conduct, drug quality or manufacturing issues; existing ONPATTRO polyneuropathy indication unchanged.","Alnylam will no longer pursue expanded U.S. indication for patisiran; focus shifts to vutrisiran (HELIOS-B Phase 3) and ALN-TTRsc04.","FDA advisory committee had voted 9:3 that benefits outweigh risks, but FDA still issued CRL.","Company to host investor call at 8:30 a.m. ET on Oct 9, 2023 to discuss the CRL."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-253084","json":"https://secwatch.observer/filing/0001193125-23-253084.json","markdown":"https://secwatch.observer/filing/0001193125-23-253084.md","text":"https://secwatch.observer/filing/0001193125-23-253084.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1178670/000119312523253084/0001193125-23-253084-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1178670/000119312523253084/d279887d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T02:02:52.250662+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"}