Lexicon Pharmaceuticals Announces Update on Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes
Lexicon Pharmaceuticals, Inc. (LXRX)
Last lexicon pharmaceuticals, inc. earnings: 4/27 07:00 am
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Source: GlobeNewswire
Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December 2024 complete response letter Company seeks alignment on reasonable path forward for Zynquista NDA resubmission FDA feedback from Type D meeting now expected during the fourth quarter THE WOODLANDS, Texas, Sept. 22, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced an update to the previous submission of additional clinical data to the U.S. Food and Drug Administration (FDA) from ongoing third-party funded, investigator-initiated studies supporting the potential resubmission of the New Drug Application for Zynquista® (sotagliflozin), an oral SGLT1/SGLT2 inhibitor, as an adjunct to insulin for glycemic control in adults with type 1 diabetes (T1D). The FDA has informed Lexicon that it requires additional time to review this data and now expects to provide feedback from the September Type D meeting in the fourth
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