{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-173444","form_type":"8-K","ticker":"ALNY","cik":"0001178670","company_name":"ALNYLAM PHARMACEUTICALS, INC.","filed_at":"2022-06-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:59.952004+00:00","generated_at":"2026-06-25T01:53:06.670308+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Alnylam gets FDA approval for AMVUTTRA (vutrisiran) for hATTR amyloidosis polyneuropathy","bullets":["FDA approval based on HELIOS-A Phase 3: 17.0-point mean improvement in mNIS+7 vs placebo (p<0.0001); 50% of patients saw improvement.","AMVUTTRA is first FDA-approved treatment for hATTR polyneuropathy with reversal of impairment; subcutaneous injection once every three months.","Launch expected early July; value-based agreements to accelerate patient access.","Under review by EMA, ANVISA, PMDA; HELIOS-B trial for cardiomyopathy ongoing.","Most common adverse reactions: arthralgia (11%), dyspnea (7%), vitamin A decreased (7%)."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-173444","json":"https://secwatch.observer/filing/0001193125-22-173444.json","markdown":"https://secwatch.observer/filing/0001193125-22-173444.md","text":"https://secwatch.observer/filing/0001193125-22-173444.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1178670/000119312522173444/0001193125-22-173444-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1178670/000119312522173444/d518443d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-25T01:53:06.670308+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"}