Shares of Eli Lilly (NYSE: LLY) are up over 8% premarket on Thursday after revealing that the FDA has granted Breakthrough Therapy designation for donanemab.
Donanemab is Eli’s investigational antibody therapy for Alzheimer’s disease.
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs intended to treat a serious condition when evidence suggests that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.
Eli Lilly’s Phase 2 trial, TRAILBLAZER-ALZ, studied the efficacy and safety of donanemab in patients with early, symptomatic Alzheimer’s disease.
The company said it intends to submit a biologics license application under the accelerated approval pathway later this year based on data from the TRAILBLAZER-ALZ trial. The safety, tolerability and efficacy of donanemab are also being evaluated in the ongoing Phase 3 study.
Eli Lily’s share price is trading 8.25% higher premarket at $235. So far this year, it is up 28.58%.
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