---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-179631"
form_type: "8-K"
ticker: "ALNY"
cik: "0001178670"
company_name: "ALNYLAM PHARMACEUTICALS, INC."
filed_at: "2023-06-30T23:59:59+00:00"
generated_at: "2026-06-13T13:44:10.938384+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Alnylam announces FDA advisory committee meeting for ONPATTRO in ATTR cardiomyopathy on Sept 13, 2023

## Summary
- FDA Advisory Committee (Cardiovascular and Renal Drugs) to review sNDA for patisiran in cardiomyopathy of ATTR amyloidosis on Sept 13, 2023.
- PDUFA action date set for October 8, 2023.
- ONPATTRO currently approved for polyneuropathy of hATTR amyloidosis; sNDA aims to expand label to cardiomyopathy.
- Safety and efficacy for cardiomyopathy indication have not yet been established by FDA.

## SEC filing metadata
- accession: 0001193125-23-179631
- form_type: 8-K
- ticker: ALNY
- cik: 0001178670
- company_name: ALNYLAM PHARMACEUTICALS, INC.
- filed_at: 2023-06-30T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1178670/000119312523179631/0001193125-23-179631-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1178670/000119312523179631/d442654d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-179631
- JSON: https://secwatch.observer/filing/0001193125-23-179631.json
- Plain text: https://secwatch.observer/filing/0001193125-23-179631.txt

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