Eli Lilly Says Timing Of Expected FDA Action On Donanemab Will Be Delayed Beyond Q1 Of 2024
Portfolio Pulse from Benzinga Newsdesk
Eli Lilly announced that the FDA's decision on Donanemab, a treatment for Alzheimer's, will be delayed beyond Q1 of 2024. The FDA seeks to further understand the safety and efficacy of Donanemab, focusing on its safety results and the unique trial design of the TRAILBLAZER-ALZ 2 study. This includes its limited-duration dosing regimen and the inclusion of participants based on tau levels.
March 08, 2024 | 11:47 am
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Eli Lilly's expected FDA action on Donanemab for Alzheimer's treatment will be delayed beyond Q1 2024, as the FDA requires more information on its safety and efficacy.
The delay in FDA approval for Donanemab is likely to negatively impact Eli Lilly's stock in the short term due to the postponement of potential revenue from this new treatment. The FDA's request for more information on safety and efficacy, along with concerns about the trial design, introduces uncertainty about the drug's approval timeline and its market potential.
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