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FDA Pushes Back Review of Lexicon Diabetes Drug Data

Provided by Dow Jones Sep 22, 2025, 8:41:00 PM

By Nicholas G. Miller

The FDA said it would delay feedback on a diabetes drug developed by Lexicon previously expected by the end of the month, saying it needed more time to review data Lexicon submitted.

The drug, called Zynquista, is an adjunct to insulin used for glycemic control in adults with type 1 diabetes. Lexicon had expected feedback by the end of September but now expects feedback in the fourth quarter.

Last December, the FDA expressed concerns of increased risk of diabetic ketoacidosis and requested additional data. Lexicon then submitted data from three ongoing studies supporting the benefit-risk profile of the drug.

Write to Nicholas G. Miller at nicholas.miller@wsj.com.

(END) Dow Jones Newswires

September 22, 2025 16:41 ET (20:41 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.

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