secwatch.observer — SEC 8-K summary
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Issuer:     ALNYLAM PHARMACEUTICALS, INC. (ALNY)
CIK:        0001178670
Form:       8-K
Filed at:   2022-06-14T23:59:59+00:00
Accession:  0001193125-22-173444
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Alnylam gets FDA approval for AMVUTTRA (vutrisiran) for hATTR amyloidosis polyneuropathy
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- FDA approval based on HELIOS-A Phase 3: 17.0-point mean improvement in mNIS+7 vs placebo (p<0.0001); 50% of patients saw improvement.
- AMVUTTRA is first FDA-approved treatment for hATTR polyneuropathy with reversal of impairment; subcutaneous injection once every three months.
- Launch expected early July; value-based agreements to accelerate patient access.
- Under review by EMA, ANVISA, PMDA; HELIOS-B trial for cardiomyopathy ongoing.
- Most common adverse reactions: arthralgia (11%), dyspnea (7%), vitamin A decreased (7%).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1178670/000119312522173444/0001193125-22-173444-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1178670/000119312522173444/d518443d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-173444

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