|Company Name||SteadyMed Ltd.|
On August 31, 2017, SteadyMed announced that it received a Refusal to File letter from the FDA in connection with its New Drug Application (“NDA”) for Treyvent, a pulmonary arterial hypertension treatment. Based on a preliminary review of the NDA, which was submitted in June of 2017, the FDA determined that the application is not sufficiently complete to permit a substantive review.
On this news, SteadyMed's share price fell 33% on August 31, 2017, thereby injuring investors.
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