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Lexicon Voluntarily Withdraws Sotagliflozin New Drug Application and Plans Prompt Resubmission Targeted Early Q2 2022
Resubmission to Correct Recently-Identified Technical Issue Conference Call and Webcast at 8:00 am Eastern Time THE WOODLANDS, Texas, Feb. 28, 2022 (GLOBE
About this update from Lexicon Pharmaceuticals, Inc.
[{"type":"text","content":"Resubmission to Correct Recently-Identified Technical Issue Conference Call and Webcast at 8:00 am Eastern Time THE WOODLANDS, Texas, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the voluntary withdrawal and planned near-term resubmission of the company’s New Drug Application (NDA) for sotagliflozin to correct a technical issue with the submission recently identified by the company. The company promptly notified the U.S. Food and Drug Administration (FDA) about the issue and has been in discussions with the agency to correct the submission. Due to the proximity to the conclusion of the 60-day filing review period, Lexicon determined, after consultation with the FDA, that the withdrawal of the NDA and a subsequent resubmission would be the most appropriate action to provide a complete submission for review. “The NDA resubmission is our top priority,” said Lonnel Coats, Lexicon’s chief executive officer. “We consider our ongoing dialogue with the FDA to be encouraging and are targeting a resubmission early in the second quarter of 2022.” Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am CT. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 8051406. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days. About Sotagliflozin Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transfor...