After Eli Lilly (LLY) announced it received a Complete Response Letter, or CRL, from the FDA for its biologic license application for lebrikizumab for atopic dermatitis, or AD, Morgan Stanley analyst Terence Flynn called the news “disappointing,” but added that the impact is “likely limited.” The letter stated no concerns about the clinical data package, safety or label for lebrikizumab and no other marketed or pipeline Lilly products are affected, notes the analyst, who models 2023/2024 lebrikizumab U.S. sales of $40M and $160M, respectively, which represent less than 1% of total sales. The firm models 2030 worldwide sales for the potential competitor to Regeneron (REGN) and Sanofi’s (SNY) Dupixent of $1.5B, or about 2% of total forecast Lilly revenue. The firm has an Overweight rating and $640 price target on Eli Lilly shares.
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