FDA lifts hold on Denali's PD candidate

Denali Therapeutics Inc. (NASDAQ:DNLI) said FDA lifted a partial clinical hold on a Phase I study of Parkinson's disease candidate DNL201. It is a leucine-rich repeat kinase 2 (LRRK2) inhibitor.

The agency placed the hold based on preclinical toxicity data to impose an exposure cap that only allowed Denali to test DNL201 up to a dose it believed would be sufficient to achieve 50% inhibition of LRRK2 on average. The company said FDA lifted the hold following review of the data from the trial and additional preclinical results...