According to the law firm press release, ARIAD Pharmaceuticals, Inc. ("ARIAD" or the Company) is a global oncology company focused on the discovery, development and commercialization of medicines to transform the lives of cancer patients. The Company's approach to structure-based drug design has led to several molecularly targeted medicines for drug-resistant or difficult-to-treat cancers.
The Complaint alleges that throughout the Class Period, Defendants represented that the Company's leukemia drug Iclusig (ponatinib), based on its clinical data from its pivotal PACE trial of Iclusig, was safe and effective, without serious adverse events such as serious arterial thrombotic and cardiovascular events. Specifically, on December 11, 2011, ARIAD announced preliminary clinical data from the PACE trial, which purportedly yielded "strong clinical evidence of the anti-leukemic activity of ponatinib". Moreover, the Company touted the "favorable safety and tolerability profile of ponatinib". Based upon these representations, the Company achieved FDA approval for Iclusig on December 14, 2012.
On October 9, 2013, the Company updated the data from its PACE trial, revealing that the drug was shown to cause a higher rate of blood clots and heart-related side effects than previously disclosed. Specifically, the Company disclosed that serious arterial thrombosis occurred in a staggering 11.8% of Iclusig-treated patients, and that 6.2% of the patients had cerebrovascular events. As a result, the FDA placed a hold on new patient enrollment for Iclusig testing, and the Company advised patients currently receiving the drug to lower their dosage. On this news, ARIAD shares declined $11.31 per share or nearly 66%, to close at $5.83 per share on October 9, 2013.
On January 9, 2014, the Court issued an Order consolidating actions, appointing lead Plaintiffs, and approving lead Counsel. Lead Plaintiffs filed a consolidated Complaint on February 18. A corrected version of this Complaint was filed on March 25.
On March 25, 2015, the Court issued an Order dismissing this case. Plaintiff filed a Notice of Appeal on April 21. On November 28, 2016, the Court of Appeals issued a judgment reversing in part the decision of the District Court and remanding for proceedings consistent with their opinion.
On November 30, 2017, the parties entered into a Stipulation of Settlement. On May 10, 2018, the Court granted final approval of the Settlement and entered Final Judgment. On July 10, 2019, the Court issued an Order granting distribution of the Settlement to authorized claimants.