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Key Takeaways
- Eli Lilly & Co. on Friday announced that the release of its experimental Alzheimer’s drug will be delayed as the Food and Drug Administration looks more closely at its Phase 3 trial results.
- The drug maker said it was surprised at the decision, and that approval of the treatment won’t come until after the first quarter.
- The news lifted shares of Biogen Inc., which already has a rival Alzheimer’s medicine on the market, while shares of Eli Lilly lost ground.
Shares of Eli Lilly & Co. ( LLY ) were down more than 2% Friday after the pharmaceutical company announced that the Food and Drug Administration (FDA) wants more information about its experimental Alzheimer’s treatment, donanemab, which will delay its release.
The company said the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to look into the Phase 3 trial results of donanemab. It explained the committee would be discussing “the efficacy and safety of donanemab in early symptomatic Alzheimer’s disease.”
Lilly added that the date of the advisory group meeting has yet to be determined by the FDA, so anticipated approval action by officials on donanemab won’t happen until after the first quarter.
Anne White, executive vice president of Lilly and president of Lilly Neuroscience, said the drug maker was surprised by the FDA decision, and is “confident in donanemab’s potential to offer very meaningful benefits to people with early symptomatic Alzheimer’s disease.”
Lilly said that the FDA’s move won’t affect the company’s 2024 financial guidance .
The news boosted shares of Biogen Inc. ( BIIB ) Friday, because donanemab would be a rival to its own Alzheimer’s drug, Leqembi. Biogen was up almost 2.5% to $224.83 at around 2:30 p.m. ET.
Eli Lilly shares were down 2.2% at $763.00. Despite the decline, the stock has gained nearly 30% since the start of the year.