Lexicon Pharmaceuticals reported its Q2 2022 financial results, highlighted by the acceptance of the sotagliflozin New Drug Application (NDA) for heart failure by the FDA and positive top-line results from its Phase 2 RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy.
Sotagliflozin NDA for heart failure accepted for review by FDA, with PDUFA action date anticipated in May 2023.
LX9211 Phase 2 clinical proof-of-concept achieved in painful diabetic neuropathy.
A poster was presented evaluating the effect of sotagliflozin on major adverse cardiovascular events (MACE).
Patient enrollment continued in the Phase 2 proof-of-concept study of LX9211 for the treatment of post-herpetic neuralgia (RELIEF-PHN-1), from which top-line results are expected in the fourth quarter of 2022.
Lexicon expects to report top-line results in the fourth quarter of this year from a second proof-of-concept study of LX9211 in post-herpetic neuralgia.