FDA lifts partial hold on Regulus’ early-stage study of RGLS4326

The FDA has removed the partial clinical hold on a Phase 1 study evaluating Regulus Therapeutics’ (RGLS -0.1%) RGLS4326 for the potential treatment of autosomal-dominant polycystic kidney disease. The trial should restart next quarter.

The FDA instituted the partial hold, which suspends recruitment, after “unexpected findings” in a mouse toxicity study in July.

https://seekingalpha.com/news/3526517-fda-lifts-partial-hold-on-regulus-early-stage-study-of-rgls4326