The U.S. Food and Drug Administration (FDA) has accepted for review Lexicon Pharmaceuticals ‘ (NASDAQ:LXRX) New Drug Application (NDA) for sotagliflozin for the treatment of heart failure.

The regulatory agency has assigned a standard review with a PDUFA target action date in May 2023.

The regulatory submission is supported by the data readout from the Phase 3 SOLOIST-WHF clinical study in patients with type 2 diabetes who had recently been hospitalized for worsening heart failure and the Phase 3 SCORED clinical study in patients with type 2 diabetes, chronic kidney disease and risks for cardiovascular disease.

The company is planning for commercial launch of the drug by the middle of next year.

Price Action : Lexicon shares are trading higher at $3.14 on Wednesday at the time of publication.