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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