Lin Tsai's questions to LEXICON PHARMACEUTICALS (LXRX) leadership • Q1 2025
Question
Lin Tsai of Bank of America inquired about the clinical development plan for pilavapadin, asking about the design and number of planned Phase III studies, the potential timeline for data readouts, and what additional studies would be required for an NDA submission.
Answer
Dr. Craig Granowitz, SVP and Chief Medical Officer, confirmed plans for two parallel Phase III trials (one US-only, one global) with similar designs, each enrolling approximately 300-350 patients per arm. He stated a third trial is not deemed necessary due to the robust signal observed. For NDA submission, he highlighted the need for addiction liability studies, additional metabolism studies, and long-term preclinical trials, while expressing confidence in the existing manufacturing process.