Lexicon Pharmaceuticals, Inc. announced on September 22, 2025, an update regarding its submission of additional clinical data to the U.S. Food and Drug Administration (FDA) for Zynquista (sotagliflozin) in type 1 diabetes (T1D). The FDA informed Lexicon that it requires additional time to review the submitted data.
Consequently, the FDA now expects to provide feedback from the September Type D meeting in the fourth quarter of 2025, a delay from the previously anticipated timeline of by the end of September. This data was submitted to support a potential resubmission of the New Drug Application (NDA) following the Complete Response Letter issued in December 2024.
The submitted data came from three ongoing third-party funded, investigator-initiated studies (STENO1, SUGARNSALT, and SOPHIST) supporting the benefit-risk profile of Zynquista in T1D. The delay prolongs the uncertainty surrounding the regulatory path forward for Zynquista.
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