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Update: Market Chatter: Eli Lilly's Weight-Loss Pill May Get FDA Approval by Year-End
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Update: Market Chatter: Eli Lilly's Weight-Loss Pill May Get FDA Approval by Year-End
Sep 16, 2025 8:14 AM

10:49 AM EDT, 09/16/2025 (MT Newswires) -- (Updates with FDA response in the fourth and fifth paragraphs.)

Eli Lilly's ( LLY ) investigational oral weight-loss drug orforglipron could be approved by the US Food and Drug Administration before the end of the year under a new one-to-two-month priority review process, Reuters reported Tuesday, citing Wall Street analysts.

Analysts see the drug as a strong candidate for the fast-track program, which aims to speed approvals for medicines that cut costs or address major health concerns, according to the report.

Goldman Sachs ( GS ) estimates an earlier launch of the drug by one quarter would bring in another $1 billion in revenue to Lilly, the report said.

"The FDA cannot speculate on future approvals or discuss any pending applications. The FDA is committed to ensuring thorough and science-based review processes for all products. Under the law, the FDA is able to provide information on approved product applications," the agency said in a statement e-mailed to MT Newswires.

The regulator said it does not generally release information on applications that have not been approved or have yet to receive an approval.

Eli Lilly ( LLY ) did not immediately respond to MT Newswires' request for comment.

(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)

Price: 755.21, Change: +7.02, Percent Change: +0.94

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