---
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"
generated_at: "2026-06-26T09:42:40.061760+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Alnylam's vutrisiran PDUFA delayed 3 months to July 14, 2022 on packaging facility issue

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-094409
- JSON: https://secwatch.observer/filing/0001193125-22-094409.json
- Plain text: https://secwatch.observer/filing/0001193125-22-094409.txt

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