Shares of Lexicon Pharmaceuticals Inc. fell more than 10% in premarket trading on Monday after the biopharmaceutical company said it has withdrawn the new drug application for sotagliflozin that it filed last year with the U.S. Food and Drug Administration to correct a technical issue.
Lexicon, based in The Woodlands, Texas, said it voluntarily pulled the application after it identified the issues, adding that it plans resubmit the filing early in the second quarter.
Lexicon had been seeking FDA approval of sotagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent visits for heart failure in adults with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction.
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