LXRX - Lexicon soars 11% after regulatory feedback

Lexicon Pharmaceuticals (LXRX) is trading ~11.0% higher in premarket trading after announcing positive regulatory feedback for two of its late-stage trials that evaluated the cardiovascular efficacy of sotagliflozin, an oral dual inhibitor of two proteins accountable for glucose regulation.The company says that the regulatory feedback clears a key hurdle for partnership discussions around sotagliflozin in heart failure and enables a potential NDA filing in 2021.In response to a request made by Lexicon, the FDA has indicated that the results of SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (“NDA”) submission to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure.It relates to adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure.In November, Lexicon shares rose 45% in the premarket when the company announced that both SOLOIST and SCORED trial achieved their primary endpoints.

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Lexicon soars 11% after regulatory feedback