Denali receives CTA clearance for DNL919 Phase 1 study; FDA clinical hold remains unresolved

Denali Therapeutics Inc.

Denali receives CTA clearance to initiate Phase 1 study of DNL919 (ATV:TREM2) in healthy volunteers in the Netherlands.
Phase 1 single ascending dose study expected to start in Q3 2022.
FDA clinical hold on DNL919 IND remains; Denali has not yet submitted response.
Continues engagement with FDA and European regulators to define path forward, including Phase 1b in Alzheimer's.

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