Our securities attorneys are investigating claims on behalf of investors of SteadyMed Ltd. (NASDAQ: STDY) regarding possible violations of federal securities laws following the FDA’s refusal to review the company’s new drug application for Trevyent.
News of FDA Refusal to File Letter Prompts Stock Drop
On August 31, 2017, SteadyMed announced that it had received a Refusal to File letter from the FDA regarding the company’s New Drug Application for Trevyent, a treatment for pulmonary arterial hypertension. Specifically, the FDA determined, based on a preliminary review of the New Drug Application, that it was not complete enough to permit a substantive review. According to SteadyMed, the FDA requested additional information on certain device specifications and performance testing as well as additional design verification and validation testing on the final Trevyent product.
Following this news, SteadyMed’s share price plummeted by more than 44% in intraday trading, to ultimately close down more than 35% at $3.80 on August 31, 2017.
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