---
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"
generated_at: "2026-05-24T08:30:37.857319+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Alnylam gets FDA approval for AMVUTTRA in ATTR-CM, first RNAi therapy for cardiomyopathy

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001178670-25-000038
- JSON: https://secwatch.observer/filing/0001178670-25-000038.json
- Plain text: https://secwatch.observer/filing/0001178670-25-000038.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.