September 1, 2017 (Shareholders Foundation) - An investigation on behalf of investors of Steadymed Ltd (NASDAQ:STDY) shares over potential securities laws violations by Steadymed and certain of its directors and officers in connection with certain financial statements was announced.

The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Steadymed Ltd (NASDAQ:STDY) concerning whether a series of statements by Steadymed Ltd regarding its business, its prospects and its operations were materially false and misleading at the time they were made.

Israel based SteadyMed Ltd. is a specialty pharmaceutical company that is focused on the development and commercialization of various therapeutic product candidates. Steadymed Ltd reported that its annual Total Revenue rose from $0.87 million in 2015 to $1.06 million in 2016 and that its Net loss increased from $24.97 million in 2015 to $25.87 million in 2016.

Shares of Steadymed Ltd (NASDAQ:STDY) grew from $2.60 per share in early 2017 to as high as $7.50 per share in April 2017.

On August 31, 2017, Steadymed Ltd announced receipt of a Refusal to File letter from the U.S. Food and Drug Administration ('FDA') concerning the Company's New Drug Application ('NDA') for Treyvent, a pulmonary arterial hypertension treatment. Based on a preliminary review of the NDA, which was submitted in June 2017, the FDA determined that the application is not sufficiently complete to permit a substantive review.

Shares of Steadymed Ltd (NASDAQ:STDY) declined to $3.35 per share on August 31, 2017.