| 2021-06-24 07:22:30|
LLY, BIIB 07:22 06/24 06/24/21
Eli Lilly jumps on expedited plans for Alzheimer's drug, Biogen falls
Eli Lilly (LLY) announced that the Food and Drug Administration granted Breakthrough Therapy designation for donanemab, its investigational antibody therapy for Alzheimer's disease. Lilly intends to submit a biologics license application for donanemab under the accelerated approval pathway later this year based on data from TRAILBLAZER-ALZ. The safety, tolerability and efficacy of donanemab are also being evaluated in the ongoing Phase 3 study TRAILBLAZER-ALZ 2, the company said in a statement. The Phase 2 trial, TRAILBLAZER-ALZ, studied the efficacy and safety of donanemab in patients with early, symptomatic Alzheimer's. Shares of Eli Lilly are up 9%, or $18.50, to $235.60 following the news. Shares of Biogen (BIIB), who recently received FDA approval for its Alzheimer's treatment, are down 6% to $350.02 in premarket trading.