FDA puts hold on Denali's DNL919 IND application

14 January 2022

Shares of US neurodegenerative diseases focussed biotech firm Denali Therapeutics (Nasdaq: DNLI) slumped 13% to $33.53 by late afternoon yesterday, after the company revealed it was informed via e-mail communication from the US Food and Drug Administration that the Investigational New Drug (IND) application for its Alzheimer’s disease candidate DNL919 (ATV:TREM2) has been placed on clinical hold.

The FDA indicated that it will provide an official clinical hold letter to Denali in approximately 30 days. Denali plans to provide additional updates pending discussion with the FDA.

The news comes just days after Japanese partner Takeda (TYO: 4502) exercised its option to co-develop and co-commercialize DNL919 in Alzheimer’s disease making this the second TV-enabled program partnered with Takeda in addition to DNL593 (PTV:PGRN) in frontotemporal dementia-granulin (FTD-GRN). Takeda paid Denali an upfront $150 million when the original collaboration was announced in 2018.

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