On the heels of its Alzheimer’s treatment receiving “breakthrough therapy” designation from the Food and Drug Administration, shares of Eli Lilly soared in early trading Thursday.
The drugmaker hit an all-time high after receiving the FDA’s stamp of preapproval, which the agency grants to treatments that may show substantial improvement over existing therapies. Shares were up more than 9% at 10:20 a.m. ET, gaining more than 20 points and moving as high as $239.37.
Lilly said it plans to apply for expedited approval of the drug, called donanemab. The news came weeks after Biogen’s competing, controversial Alzheimer’s drug was approved. (Three members of a FDA advisory panel resigned over that approval, saying it was ill-advised.)
Donanemab is designed to remove protein clumps called “beta amyloid” from the brain. That protein is linked to the disease and is believed to be a possible cause.
The “breakthrough therapy” designation is a win for Lilly, which has been trying to combat Alzheimer’s for years. Previous attempts in 2016 and 2018 failed in trials.
Lilly’s triumph is weighing on Biogen shares. That company’s stock was down over 4% in early trading Thursday as investors absorbed the news.
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