Regulatory Delay for Zynquista Casts Shadow Over Lexicon’s Prospects

Lexicon Pharmaceuticals faces a significant postponement in its regulatory timeline for Zynquista. The U.S. Food and Drug Administration (FDA) has announced it requires additional time to evaluate clinical data for the Type 1 diabetes treatment. A key Type D meeting, initially anticipated for the end of September, has now been pushed back to the fourth quarter of 2025. Reflecting this setback, Lexicon’s stock closed Monday’s session down 2.59% at $1.16, though it saw a modest after-hours recovery to $1.19.

While the delay for Zynquista prolongs uncertainty regarding its potential approval as an insulin adjunct therapy, Lexicon is actively advancing other promising candidates. The company recently submitted additional clinical data from three third-party-funded studies to address FDA concerns about diabetic ketoacidosis (DKA) risk, which were... Read more...