Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) has voluntarily withdrawn and planned near-term resubmission of the sotagliflozin U.S. application to correct a technical issue with the submission recently identified by the company.
- Lexicon has notified the FDA about the issue and has discussed with the agency to correct the submission.
- The company applied in Q4 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.
- Related: Lexicon's Sotagliflozin Shows Benefits in Heart Failure, Blood Glucose Control.
- "The NDA resubmission is our top priority," said Lonnel Coats, Lexicon's CEO. "We consider our ongoing dialogue with the FDA to be encouraging and are targeting a resubmission early in the second quarter of 2022."
- The company ended 2021 with $86.7 million in cash and investments.
- Price Action: LXRX shares are down 14% at $2.45 during the premarket session on the last check Monday.
