secwatch.observer — SEC 8-K summary
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Issuer:     ALNYLAM PHARMACEUTICALS, INC. (ALNY)
CIK:        0001178670
Form:       8-K
Filed at:   2023-06-30T23:59:59+00:00
Accession:  0001193125-23-179631
Event type: regulatory
Sentiment:  neutral
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1178670/000119312523179631/0001193125-23-179631-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1178670/000119312523179631/d442654d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-179631

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