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Eli Lilly (NYSE:LLY) Stocks have been doing pretty well this year, but a new development changed that momentum on Friday. The company’s shares fell as much as 3.2% Friday afternoon on news that the top regulator was delaying a decision on one of the company’s most important new drug candidates.
FDA decision on Alzheimer’s drug delayed
That regulatory authority is none other than the Food and Drug Administration (FDA), a powerful U.S. government agency. On Friday, Eli Lilly announced that the FDA had unexpectedly delayed a decision on its Alzheimer’s disease drug donanemab.
The FDA informed the company that it would hold a last-minute advisory meeting to further review the drug’s performance in Phase 3 trials, but did not say when the meeting would take place, so it is unclear when that meeting will take place.
Pharmaceutical companies and many stakeholders believed that regulators would make a decision on donanemab’s approval by the end of this month.
Donanemab has performed well in clinical trials, but like other Alzheimer’s drugs, there are safety concerns. The main cause is swelling and bleeding in the brain. Eli Lilly said the root of the FDA’s concerns is the therapy’s safety and effectiveness.
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Not surprisingly, Eli Lilly continues to support Alzheimer’s disease candidates. “We are confident in donanemab’s potential to provide very meaningful benefits for patients with early-stage symptomatic Alzheimer’s disease,” the Journal quoted Anne White, director of Lilly’s neuroscience division, as saying.
He added that the company hopes to present further results from late-stage clinical trials and has promised to “work with FDA and community stakeholders to present and answer all questions.”
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Eric Volkman has no position in any stocks mentioned. The Motley Fool has no position in any stocks mentioned. The Motley Fool has a disclosure policy.
The article Why Eli Lilly Stock Drops on Friday was published by The Motley Fool.
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