De­nal­i's Alzheimer's drug faces set­back at the FDA af­ter agency slaps clin­i­cal hold on hu­man tri­al start

De­nali Ther­a­peu­tics was once a Cin­derel­la sto­ry in neu­rol­o­gy with high ex­pec­ta­tions on a plat­form it thinks could of­fer much greater brain pen­e­tra­tion. Since then, that rep­u­ta­tion has dimmed some­what — and a new clin­i­cal hold won’t make any new fans.

The FDA has placed a clin­i­cal hold on De­nali’s IND for DNL919, an Alzheimer’s can­di­date tar­get­ing the pro­tein cod­ing gene TREM2, the biotech an­nounced in a terse state­ment Thurs­day.

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