Lexicon Pharmaceuticals Nears Critical Regulatory Milestone

Lexicon Pharmaceuticals finds itself at a pivotal moment. Following substantial progress within its drug development pipeline and notable stock price volatility in recent months, investor focus has shifted squarely to the upcoming decision from the U.S. Food and Drug Administration (FDA).

The company took a significant step this week by submitting additional clinical data to the FDA for Sotagliflozin (Zynquista). This SGLT1/SGLT2 inhibitor is under review for use alongside insulin in adults managing type 1 diabetes. This latest submission directly addresses concerns the regulatory body raised in a December 2024 communication, which highlighted a potential increased risk of diabetic ketoacidosis. Lexicon anticipates receiving feedback from the agency as soon as September, marking a crucial juncture for the drug’s... Read more...