secwatch.observer — SEC 8-K summary
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Issuer:     ALNYLAM PHARMACEUTICALS, INC. (ALNY)
CIK:        0001178670
Form:       8-K
Filed at:   2025-03-21T23:59:59+00:00
Accession:  0001178670-25-000038
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1178670/000117867025000038/0001178670-25-000038-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1178670/000117867025000038/alny-20250320.htm
  HTML page:      https://secwatch.observer/filing/0001178670-25-000038

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer