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Zynquista (sotagliflozin)
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Lexicon reports FDA's decision to extend review period for Zynquista
Seeking Alpha· 2025-09-23 04:30
Lexicon Pharmaceuticals (NASDAQ:LXRX) said that the FDA has asked for additional time to review additional data for the potential resubmission of the marketing application for Zynquista (sotagliflozin) in adults with type 1 diabetes. This submission of additional clinical data follows ...
Lexicon Pharmaceuticals Announces Update on Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes
Globenewswire· 2025-09-23 04:00
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. Fo ...