Business
Lexicon Pharmaceuticals Reports Third Quarter 2022 Financial Results And Provides Business Update
NDA for Sotagliflozin Remains on Track for May 2023 PDUFA Date Following Mid-Cycle Review Meeting Final Data from Successful RELIEF-DPN-1 Study of LX9211 in
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"NDA for Sotagliflozin Remains on Track for May 2023 PDUFA Date Following Mid-Cycle Review Meeting Final Data from Successful RELIEF-DPN-1 Study of LX9211 in Painful Diabetic Neuropathy to Be Presented at 16th Annual Pain Therapeutics Summit Next Week Conference Call and Webcast at 5:00 pm Eastern Time THE WOODLANDS, Texas, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended September 30, 2022 and provided an update on key corporate milestones. “Our mid-cycle review meeting with the FDA was held this week for our NDA for sotagliflozin for the treatment of heart failure, which remains on track for its PDUFA action date in May 2023,” said Lonnel Coats, Lexicon’s chief executive officer. “This past weekend, important data for sotagliflozin were presented at two major medical conferences, notably including an oral presentation at the American Heart Association Scientific Sessions 2022 on reduced cardiovascular mortality and hospital readmissions for heart failure at 30- and 90-days post discharge in patients hospitalized for worsening heart failure in the SOLOIST-WHF trial.” “This coming Monday, final data from our successful RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy will be presented at the 16th Annual Pain Therapeutics Summit in Washington, D.C., which we will follow with a conference call discussing the results and their importance in an area of significant unmet need,” Mr. Coats continued. “Finally, we completed enrollment earlier this quarter in our RELIEF-PHN-1 study of LX9211 in post-herpetic neuralgia, from which we expect to report top-line data before year-end.” Third Quarter Highlights Sotagliflozin The U.S. Food and Drug Administration (FDA) accepted for review and filed Lexicon’s New Drug Application (NDA) for sotagliflozin for the treatment of heart failure. The FDA assigned a standard review for the NDA filing with a Prescription Drug User Fee Act (PDUFA) target action date in May 2023.Two posters were presented at the 70th annual European Society of Cardiology Congress, highlighting protein expression analyses comparing sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, with a selective SGLT2 inhibitor in cell-based models relative to inflammation and thrombosis. The first poster, “Sotagliflozin, a Dual SGLT1/2 Inhi...