FDA delays PDUFA date for Lexicon's telotristat etiprate

The US Food and Drug Administration will require additional time to complete its review of the New Drug Application for telotristat etiprate, an oral drug for the treatment of carcinoid syndrome, the drug’s developer Lexicon Pharmaceuticals (Nasdaq: LXRX) revealed yesterday.

Following the news late yesterday, Lexicon’s shares dipped 4.35% to $18.83 in pre-market trading this morning. The firm’s shares had been on the rise recently, after it releases positive new data on its sotagliflozin in patients with type 1 diabetes.

In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of telotristat etiprate has been extended by three months, from November 30, 2016 to February 28, 2017. In response to an information request from the FDA, additional clinical data analyses have been submitted and the extension will provide the FDA time for a full review of the submission.