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SteadyMed falls on Trevyent NDA refusal

August 31, 2017 8:54 PM UTC

SteadyMed Ltd. (NASDAQ:STDY) lost $2.10 (36%) to $3.80 on Thursday after 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. ...

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