Lilly acquires Point Biopharma amid third FDA rejection in 2023

Eli Lilly and Company has recently received its third FDA rejection for the year 2023. The most recent came for lebrikizumab, the company’s investigational treatment for atopic dermatitis. FDA made the decision following an inspection of a third-party contract manufacturing organization. The agency had no complaints concerning the clinical data, safety, or labeling of lebrikizumab, but instead focused on quality control deficits.

Setbacks earlier in the year

Before the lebrikizumab setback, Lilly faced rejections for another antibody, mirikizumab, intended for ulcerative colitis. Donanemab, its Alzheimer’s disease was also affected. The former’s rejection also stemmed from manufacturing-related issues, while the latter faced concerns regarding the limited patient exposure during clinical trials.

Despite the hurdles, Lilly has fared extremely well on the stock market in 2023. Its share price is up more than 40% so far in 2023, trading most recently at $517…

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