Why Eli Lilly (LLY) Shares Are Trading Lower Today - Eli Lilly (NYSE:LLY)

The FDA issued a complete response letter for the accelerated approval submission of Eli Lilly And Co's LLY donanemab for early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission.
No other deficiencies in the application were noted.
The confirmatory Phase 3 TRAILBLAZER-ALZ 2 trial remains ongoing, with topline data read-out expected in Q2 2023, and will form the basis of donanemab's application for traditional approval shortly after that.
In the complete response letter to the accelerated approval application, the FDA requested that Lilly provide data from at least 100 patients who received a minimum of 12 months of continued treatment on donanemab.
All eyes were on donanemab when Biogen Inc BIIB gained accelerated FDA approval earlier this month.
While the trial included more than 100 patients treated with donanemab, due to the speed of plaque reduction, many patients could stop dosing as early as six months, resulting in fewer than 100 patients receiving 12 months of donanemab.
The FDA indicated that the data to meet the exposure expectation would need to include the unblinded controlled safety data from TRAILBLAZER-ALZ 2 upon completion.
Price Action: LLY shares traded 2.07% lower at $343.81 during the pre-market trading on Friday.
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FDA Rejects Eli Lilly's Donanemab For Alzheimer's Disease, Needs More Data