FDA Places Hold on Denali Therapeutic’s IND for DNL919 Alzheimer’s Therapeutic

Denali Therapeutics announced the U.S. FDA has placed a hold on the Investigational New Drug (IND) application for DNL919, under development for the treatment of Alzheimer’s disease (AD). The FDA indicated they will provide an official clinical hold letter to Denali in approximately 30 days. Denali plans to provide additional updates pending discussion with the FDA. A few days prior to the hold, Denali presented program progress and expected milestones for 2022 during a corporate presentation at the 40th Annual J.P. Morgan Healthcare Conference. During this presentation, the company announced that Takeda exercised its option in December 2021 to co-develop and co-commercialize DNL919 for the treatment of AD and that the IND application for DNL919 had been submitted. Denali had hoped to begin first-in-human clinical trials of DNL919 in the first half of 2022, with human safety and biomarker data available in the second half of 2022.  

DNL919 (ATV:TREM2) is an Antibody Transport Vehicle (ATV) designed to activate TREM2 (ATV:TREM2) and improve microglial function. TREM2 is a receptor expressed on microglia, the resident immune cells of the brain. Loss of function TREM2 genetic muta…

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