FDA refuses NDA for SteadyMed's Trevyent

SteadyMed Ltd. (NASDAQ:STDY) said FDA issued a refusal to file letter to an NDA for Trevyent treprostinil to treat pulmonary arterial hypertension (PAH). FDA said the application was not complete and requested additional information on device specifications and performance testing, as well as additional design verification and validation testing.

In 2015, SteadyMed granted Cardiome Pharma Corp. (TSX:COM; NASDAQ:CRME) exclusive rights to commercialize Trevyent in Europe, Canada and the Middle East (see BioCentury, Aug. 3, 2015)...