William Blair analyst Myles Minter noted that Eli Lilly (LLY) announced that the FDA had issued a complete response letter, or CRL, for the donanemab BLA seeking accelerated approval for the treatment of Alzheimer’s disease, calling the news a "positive headline" for Eisai (ESALY) and Biogen’s (BIIB) Leqembi. While he now anticipates a slight delay for donanemab to potentially enter the market in 2024, he does not believe this news has any impact on the competitive landscape until the TRAILBLAZER-ALZ2 trial reads out. Minter reiterates an Outperform rating on Biogen based on what he sees as "the substantial Leqembi opportunity."
Published first on TheFly
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