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Lexicon Pharmaceuticals Reports Fourth Quarter and Full-Year 2021 Financial Results and Provides Clinical Update
Conference Call and Webcast at 8:00 am Eastern Time THE WOODLANDS, Texas, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"Conference Call and Webcast at 8:00 am Eastern Time\nTHE WOODLANDS, Texas, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today reported financial results for the three months and full-year ended December 31, 2021 and provided an update on key milestones. “We remain focused on advancing sotagliflozin for the millions of people suffering from heart failure and living with type 2 diabetes on a daily basis. We announced today that we voluntarily withdrew the sotagliflozin NDA to correct a technical issue that we recently identified, and we plan to promptly resubmit early in the second quarter of 2022,” said Lonnel Coats, Lexicon’s chief executive officer. “In addition, we are looking forward to completing and announcing top-line results in the coming months from our two proof-of-concept Phase 2 studies of LX9211 in diabetic peripheral neuropathic pain and post-herpetic neuralgia.” Fourth Quarter Highlights Sotagliflozin Lexicon submitted a New Drug Application (NDA) to the FDA at the end of the fourth quarter of 2021 seeking approval for the marketing and sale of sotagliflozin, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction. Today, Lexicon announced its voluntary withdrawal and planned near-term resubmission of the NDA to correct a technical issue with the submission recently identified by the company.A new analysis evaluating the clinical benefit of sotagliflozin in heart failure and blood glucose control across the full range of kidney function was presented at the American Heart Association Scientific Sessions 2021. Sotagliflozin significantly reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure, as well as decreased hemoglobin A1c, across the full range of kidney function studied, including individuals with moderate-to-severe chronic kidney disease. LX9211 Patient enrollment continued in two ongoing Phase 2 clinical studies of LX9211: RELIEF-DPN-1 for the treatment of diabetic peripheral neuropathic pain and RELIEF-PHN-1 for the treatment of post-herpetic neuralgia. Lexicon anticipates completing recruitmen...