According to the law firm press release, Regado is a biopharmaceutical company that focuses on the discovery and development of antithrombotic drug systems for acute and sub-acute cardiovascular and other indications.
The Complaint alleges that throughout the Class Period, Defendants made false and/or materially misleading statements, and failed to disclose material adverse facts about the Company's business, operations, prospects and performance. Specifically, during the Class Period, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the danger and frequency of allergic reactions experienced by subjects in the REG1 Phase 3 trial were significant enough to derail the trial; (ii) the allergic reactions were of such a serious nature and/or frequency that the Data Safety Monitoring Board ("DSMB") and FDA would ultimately be required to place the clinical trial on hold; and (iii) and as a result of the above, the Company's financial statements were materially false and misleading at all relevant times.
On July 3, 2014, the Company announced that the DSMB overseeing the REG1 clinical trial commenced an "unplanned review" to determine the "safety and treatment benefit-risk ratio" of all the 3,234 patients who had been enrolled in the study to date. As a result, Regado ceased enrolling patients in the study and announced that it would suspend the trial until the review was complete.
On this news, Regado stock fell $3.95, or over 58%, on unusually heavy volume, to close at $2.81 on July 3, 2014.
On July 9, 2014, after the market closed, the Company announced that, further to their decision to voluntarily pause enrollment in the REG1 study, the FDA informed the Company that a clinical hold has been placed on all patient enrollment and dosing in the ongoing Phase 3 trial.
On this news, Regado stock fell $0.20, or over 7%, on unusually heavy volume, in intraday trading on July 10.
On September 26, 2014, the Court issued an Order consolidating actions, appointing lead plaintiff, and approving the selection of lead counsel.
In accordance with a Stipulation by the parties, this case was ordered dismissed on December 10, 2014.