FDA Places Clinical Hold On Denali's Alzheimer's Potential Program


The FDA has issued a clinical hold on Denali Therapeutics Inc's DNLI Investigational New Drug (IND) application for DNL919 TREM.

  • TREM2 is a protein expressed in microglia, the brain's resident immune cells. 
  • Mutations in the TREM2 gene are strongly associated with neuroinflammation and an increased risk for Alzheimer's disease.
  • Related content: Benzinga's Full FDA Calendar
  • ATV:TREM2 is an antibody designed to modulate TREM2 and thereby normalize microglial function 
  • The FDA agency will provide an official clinical hold letter to Denali in approximately 30 days. 
  • Denali plans to provide additional updates pending discussion with the FDA.
  • Price Action: DNLI shares are down 14.20% at $33.07 during the market session on the last check Thursday.
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