NetworkNewsBreaks – SteadyMed (NASDAQ: STDY) Shares Plunge on Refusal to File Letter from FDA for Trevyent® NDA
SteadyMed (NASDAQ: STDY) shares are down 35% this morning after the company said it has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) for Trevyent®. The Trevyent NDA was submitted in June 2017 for the treatment of Pulmonary Arterial Hypertension (PAH). Upon preliminary review of the NDA, the FDA determined that it was not adequately complete to permit a substantive review. The FDA has requested more details regarding certain device specifications and performance testing. The FDA also requested further design verification and validation testing on the final,…







