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Update: FDA Sets Target Action Date for Lexicon Pharmaceuticals' NDA Resubmission for Sotagliflozin
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Update: FDA Sets Target Action Date for Lexicon Pharmaceuticals' NDA Resubmission for Sotagliflozin
Jul 16, 2024 8:31 AM

10:56 AM EDT, 07/16/2024 (MT Newswires) -- (Adds share price movement in first paragraph).

Lexicon Pharmaceuticals ( LXRX ) rose more than 5% after the biopharmaceutical company said Tuesday the US Food and Drug Administration set a Dec. 20 target action date to complete its regulatory review and make a final market decision for its Zynquista (sotagliflozin) diabetes therapy.

The company said the FDA indicated that it considers the resubmission to be a complete response to its 2019 action letter regarding the sotagliflozin new drug application for type 1 diabetes.

"With a PDUFA (Prescription Drug User Fee Act) date now in hand, we can begin the next phase of launch preparation for Zynquista," said Lexicon Chief Executive Mike Exton.

Price: 2.24, Change: +0.12, Percent Change: +5.42

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