secwatch.observer — SEC 8-K summary
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Issuer:     ALNYLAM PHARMACEUTICALS, INC. (ALNY)
CIK:        0001178670
Form:       8-K
Filed at:   2023-10-10T23:59:59+00:00
Accession:  0001193125-23-253084
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA rejects Alnylam's patisiran sNDA for ATTR cardiomyopathy; company abandons U.S. expansion
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- FDA issued Complete Response Letter citing insufficient evidence of clinical meaningfulness for patisiran in cardiomyopathy of ATTR amyloidosis.
- No safety, study conduct, drug quality or manufacturing issues; existing ONPATTRO polyneuropathy indication unchanged.
- Alnylam will no longer pursue expanded U.S. indication for patisiran; focus shifts to vutrisiran (HELIOS-B Phase 3) and ALN-TTRsc04.
- FDA advisory committee had voted 9:3 that benefits outweigh risks, but FDA still issued CRL.
- Company to host investor call at 8:30 a.m. ET on Oct 9, 2023 to discuss the CRL.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1178670/000119312523253084/0001193125-23-253084-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1178670/000119312523253084/d279887d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-253084

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