SteadyMed (NASDAQ: STDY) – Securities Class Action Investigation
Securities attorneys with Kehoe Law Firm, P.C. 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.
On August 31, 2017, SteadyMed announced that it had received a Refusal to File letter from the FDA regarding the SteadyMed’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.
According to SteadyMed’s August 31, 2017 press release, SteadyMed
. . . a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs . . . announced receipt of a Refusal to File letter from the U.S. Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for Trevyent® for the treatment of Pulmonary Arterial Hypertension (PAH).
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. FDA has 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. Within the next 30 days, the Company will request a Type A meeting with the FDA to gain further clarification on the additional information required for resubmission and acceptance of the NDA. The Company will provide further guidance after the anticipated meeting with FDA.
Have You Purchased or Acquired SteadyMed Shares?
If you purchased or acquired SteadyMed common stock or other securities and would like to speak privately with a securities attorney to learn more about the investigation and your potential legal rights, please fill out the form to the right or contact John Kehoe, Esq., (215) 792-6676, Ext. 801, [email protected]; Michael Yarnoff, Esq., (215) 792-6676, Ext. 804, [email protected]; or send an e-mail to [email protected].
Kehoe Law Firm, P.C. is a multidisciplinary, plaintiff–side law firm dedicated to protecting investors and consumers from corporate fraud, negligence, and other wrongdoing. Driven by a strong and principled sense of social responsibility and obtaining justice for the aggrieved, Kehoe Law Firm, P.C. represents plaintiffs seeking to recover investment losses resulting from securities fraud, breaches of fiduciary duty, corporate wrongdoing or malfeasance, those harmed by anticompetitive practices, and consumers victimized by fraud, false claims, deception or data breaches. Together, the partners of Kehoe Law Firm, P.C. have spent more than 30 years prosecuting precedent-setting securities and financial fraud cases in federal and state courts on behalf of institutional and individual clients.