{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-094409","form_type":"8-K","ticker":"ALNY","cik":"0001178670","company_name":"ALNYLAM PHARMACEUTICALS, INC.","filed_at":"2022-04-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:59.951172+00:00","generated_at":"2026-06-26T09:42:40.061760+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Alnylam's vutrisiran PDUFA delayed 3 months to July 14, 2022 on packaging facility issue","bullets":["FDA extended review to July 14, 2022 due to amendment addressing inspection classification at third-party packaging/labeling facility.","New secondary packaging and labeling facility identified and submitted to FDA; no inspection observations directly related to vutrisiran.","No additional clinical data requested by FDA; vutrisiran under concurrent review by EMA, ANVISA, and PMDA.","Alnylam aims to minimize impact on other regulatory reviews through timely resolution or alternative facility."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-094409","json":"https://secwatch.observer/filing/0001193125-22-094409.json","markdown":"https://secwatch.observer/filing/0001193125-22-094409.md","text":"https://secwatch.observer/filing/0001193125-22-094409.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1178670/000119312522094409/0001193125-22-094409-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1178670/000119312522094409/d259809d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-26T09:42:40.061760+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"}