ESALF - Eli Lilly And The Alzheimer's Dilemma (Rating Upgrade)

2024-04-22 00:58:35 ET

Summary

• The FDA has convened an advisory panel to discuss the safety and efficacy of Eli Lilly's anti-amyloid antibody drug donanemab.
• Approval of donanemab could have a modestly positive impact on LLY stock, while denial could lead to a substantial (but not disastrous) drop.
• Donanemab appears to have little effect as a whole on non-APOE4 carriers, African Americans, and Hispanics.
• Alzheimer's disease appears to be primarily driven by the nitro-oxidant peroxynitrite rather than amyloid. Anti-peroxynitrite rather than anti-amyloid treatments are likely to be more successful.

The Food and Drug Administration's approval of Eli Lilly's ( LLY ) anti-amyloid antibody drug donanemab was once considered a slam dunk ( previous analysis ). But now, the FDA is convening an advisory panel to weigh in on the drug. This may just be a blip for Eli Lilly, or alternatively, concerns over donanemab's safety and efficacy could potentially lead to its rejection. Perhaps, the FDA is having approval remorse after its earlier thumbs up for Biogen ( BIIB ) and Eisai's (ESALF) Aduhelm (accelerated) and Leqembi (full)....

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