Eli Lilly Stock Plummets as FDA Delays Decision on Alzheimer’s Drug
In a surprising turn of events, Eli Lilly (NYSE: LLY) stock took a nosedive on Friday following the news that the U.S. Food and Drug Administration (FDA) has delayed its decision on the company’s Alzheimer’s disease treatment, donanemab. The shares fell by as much as 3.2% in price, disrupting the positive momentum the stock had been experiencing this year.
The FDA’s unexpected move has left investors and industry observers speculating about the future of donanemab. Eli Lilly had anticipated that the regulator would make a decision on approving the drug by the end of this month. However, the FDA has now informed the company that it will convene a last-minute meeting of advisors to further review the drug’s performance in a phase 3 trial, without specifying when the meeting will take place.
While donanemab has shown promising results in clinical testing, concerns about its safety, particularly regarding brain swelling and bleeding, have arisen. Eli Lilly acknowledged that the FDA’s concerns primarily revolve around the safety and efficacy of this potential treatment for Alzheimer’s disease.
Despite the setback, Eli Lilly remains steadfast in its support for donanemab. Anne White, the president of the Lilly Neuroscience unit, expressed confidence in the drug’s potential to provide significant benefits to individuals with early symptomatic Alzheimer’s disease. She emphasized the company’s eagerness to present the late-stage clinical trial results and its commitment to working closely with the FDA and stakeholders in the community to address any questions or concerns.
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It is important to note that Eric Volkman, the author of this article, does not hold any positions in the mentioned stocks. Additionally, The Motley Fool has no position in the stocks mentioned but maintains a disclosure policy.
The unexpected delay in the FDA’s decision on Eli Lilly’s Alzheimer’s drug has undoubtedly had a significant impact on the company’s stock performance. As investors await further updates, the future of donanemab remains uncertain. However, Eli Lilly’s commitment to addressing safety concerns and its confidence in the drug’s potential may provide some reassurance to stakeholders. Only time will tell how this setback will ultimately shape the landscape of Alzheimer’s disease treatment.