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 $517.26 in mid-day trading on October 3.
Point Biopharma acquisition
On October 3, Lilly signaled its intent to scoop up Point Biopharma for $1.4 billion. Point Biopharma is a biotech company on the verge of announcing results of a major oncology trial. As COVID-19 vaccine demand cools, oncology has emerged as the top therapeutic area. In the first half of 2023, the sector accounted for about one-fourth of drug sales, according to a recent analysis of financial data of 20 pharma firms.
Point Biopharma, which is now testing radioligand therapy candidates, PNT2002 and PNT2003, combines radioactive particles that kill cells with molecules that attach to tumors.
Lilly offered $12.50 per Point Biopharma share, an approximately 87% premium to the stock’s last close. Following the news, shares of Indiana-based Point Biopharma jumped 85%. Conversely, Lilly’s stock dipped by about 3%.
Analysts noted no regulatory risks in this acquisition, highlighting the non-overlapping nature of the therapies the two companies are developing.
The company has been on an expansion streak in 2023. It began the year by investing $450 million in a diabetes treatment manufacturing facility.
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