LXRX - Lexicon pulls U.S. marketing application for heart disease drug

The development stage biopharma company Lexicon Pharmaceuticals (NASDAQ:LXRX) has lost ~18% in the pre-market Monday after announcing that it decided to voluntarily withdraw the U.S. marketing application of sotagliflozin to correct a technical issue. In December, Lexicon (LXRX) announced the submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking its approval as a treatment for heart failure in certain patients with type 2 diabetes. After identifying the technical issue recently, Lexicon (LXRX) has promptly informed the regulator of the issue. Following discussions with the officials, the company has decided that a resubmission of the NDA would be the most appropriate action as the 60-day filing review period has approached. “We consider our ongoing dialogue with the FDA to be encouraging and are targeting a resubmission early in the second quarter of 2022,” Chief Executive Lonnel Coats remarked.

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Lexicon pulls U.S. marketing application for heart disease drug