Denali Flags Minimal Delay After FDA Halts Rare Disease Trial Start

FDA

The U.S. Food and Drug Administration (FDA) placed a clinical hold on Denali Therapeutics Inc.’s (NASDAQ:DNLI) investigational new drug (IND) application for the Phase 1 study of DNL952 under development for Pompe disease.

The FDA requested a protocol amendment to include a lower starting dose, revised inclusion criteria, certain safety monitoring commitments, and stopping rules.