Investor Alert: Kaplan Fox Announces Investigation Of SteadyMed Ltd.

NEW YORK, Sept. 1, 2017

On April 5, 2017, SteadyMed, a specialty pharmaceutical company, announced the successful completion of a clinical study for its lead drug product candidate, Trevyent, for the treatment of Pulmonary Arterial Hypertension (PAH).  Further, the Company stated that it remains on track for a New Drug Application (NDA) submission for Trevyent to treat PAH in the second quarter of 2017.

On June 30, 2017, SteadyMed announced that it had submitted the NDA to the FDA for its lead drug product candidate, Trevyent, for the treatment of PAH.

On August 31, 2017, SteadyMed announced receipt of a Refusal to File letter from the FDA concerning its NDA for Trevyent.  Based on a preliminary review of the NDA, the FDA determined that the application is not sufficiently complete to permit a substantive review.  The FDA also requested further information on certain device specifications and performance testing and has requested additional design verification and validation testing on the final, to-be-marketed Trevyent product.

Following the August 31, 2017 disclosure of the Refusal to File letter, SteadyMed's shares declined by $2.00 per share, nearly 34%, to close at $3.90 per share on heavy trading volume on August 31, 2017.

If you are an investor in SteadyMed and would like to discuss our investigation, please contact us by emailing pmayer@kaplanfox.com or by calling 800-290-1952. 

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