Lexicon Pharma更新Zynquista NDA重新提交通知，FDA在D类会议后将反馈推迟到第四季度

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 quarter, previously anticipated by end of September.

As previously disclosed, the submission of additional clinical data followed a complete response letter issued by the FDA in December 2024 that cited concerns of increased risk of diabetic ketoacidosis. Based on subsequent discussions with FDA regarding potential regulatory paths forward, Lexicon has been granted a Type D meeting and has submitted data from three ongoing studies of sotagliflozin conducted by the Steno Diabetes Center (STENO1)1, the Joslin Diabetes Center (SUGARNSALT)2 and the University of Dundee (SOPHIST)3 supporting the benefit-risk profile of Zynquista in T1D.