The U.S. Food and Drug Administration (FDA) has rejected Eli Lilly’s (NYSE:LLY) accelerated approval submission for its Alzheimer’s drug donanemab. This latest development will likely push the drug’s launch by several months. Shares were down over 2% in Friday’s pre-market trading.
In its complete response letter, the FDA has demanded trial data with at least 100 patients who took the drug continuously for a minimum period of 12 months. The pharmaceutical company had not submitted enough trial data from patients who were given the medicine for at least a year.
Eli Lilly said, “While the trial included more than 100 patients treated with donanemab, due to the speed of plaque reduction, many patients were able to stop dosing as early as 6 months of treatment, resulting in fewer than 100 patients receiving 12 months of donanemab.”
The company also informed that the Phase 3 trial for donanemab is currently ongoing and it expects to report the results in the second quarter of 2023.
Is Eli Lilly Stock a Buy, Sell, or Hold?
On TipRanks, analysts are currently optimistic about LLY stock. Eli Lilly has a Strong Buy consensus rating based on 11 Buys and two Holds. The average price target of $399.62 implies 13.8% upside potential. The stock has rallied 7% over the past three months.
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