SteadyMed Ltd. (STDY) Completes Trevyent Manufacturing Requirements for NDA Submsision

September 1, 2016 8:35 AM EDT
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SteadyMed Ltd. (Nasdaq: STDY) announced that it has completed the manufacture of all of the Trevyent batches for shelf-life studies needed to support the submission of its NDA in the first quarter of 2017.

“Trevyent, our lead drug product candidate in development for the treatment of Pulmonary Arterial Hypertension (PAH), combines SteadyMed’s proprietary, preservative free formulation of treprostinil and our PatchPump platform technology,” said Jonathan Rigby, President and Chief Executive Officer of SteadyMed. “In our latest manufacturing campaign, we have manufactured thousands of commercial Trevyent units. These units cover the concentration range of currently available Remodulin® (treprostinil, United Therapeutics) and were manufactured utilizing our final commercial supply chain infrastructure, in compliance with current Good Manufacturing Practice (cGMP) standards. We are delighted with this achievement and are now forging ahead, and on track, to submit our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in Q1 2017. Given our recent private financing transaction, as further described in our second quarter 2016 Form 10-Q, we believe we have the necessary capital to launch Trevyent in the U.S. in late 2017, if approved by the FDA.”

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