Lexicon Pharmaceuticals Reports First Quarter 2023 Financial Results and Provides Business Update

NDA for Sotagliflozin on Track for May 27th, 2023 PDUFA date

Conference Call and Webcast at 5:00 pm Eastern Time

THE WOODLANDS, Texas, May 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended March 31, 2023 and provided an update on key corporate milestones.

“Our NDA for sotagliflozin for the treatment of heart failure is on track for its May 27th PDUFA action date,” said Lonnel Coats, Lexicon’s chief executive officer. “With both recently adopted medical treatment guidelines recommending the use of SGLT inhibitors as a key pillar of heart failure treatment and the unique data from our SOLOIST-WHF trial, we believe we have a strong value proposition for clinical differentiation in the heart failure market. Should we receive regulatory approval, we are prepared to promptly launch in the United States in the first half of 2023.”  

“As we have previously shared, we continue preparations to advance LX9211 into late-stage development in neuropathic pain, supported by data from Phase 2 proof-of-concept studies in diabetic peripheral neuropathic pain (DPN) and postherpetic neuralgia (PHN), both completed in 2022, and expect feedback from our interactions from the FDA in Q2.”

First Quarter Highlights

Sotagliflozin

• On March 4th, new analyses of results from our SOLOIST-WHF Phase 3 outcomes study of sotagliflozin were presented at the American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress of Cardiology in New Orleans, Louisiana. The “Time to Clinical Benefit of Sotagliflozin in People with Worsening Heart Failure in SOLOIST-WHF” post hoc analysis examined the timing of clinical benefit of sotagliflozin, defined as the first day post randomization when the hazard ratio (HR) for risk for the primary outcome of total number of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure was statistically significant (p