Clovis Oncology, Inc.

Case Details

Class Period:
May 31, 2014 – April 7, 2016
Date Filed:
November 19, 2015
Case Number:
1:15-cv-02546
Jurisdiction:
District of Colorado

Case Summary

The Complaint alleges that throughout the Class Period, Defendants made false and misleading statements and/or failed to disclose that: (1) the New Drug Application (“NDA”) that Clovis submitted to the FDA for rociletinib contained immature data sets based on both unconfirmed response rates and confirmed response rates; (2) Clovis Breakthrough Therapy designation submission contained immature data sets based primarily on unconfirmed responses; (3) Clovis presented interim data publicly and at medical meetings that included a data set based primarily on unconfirmed responses; (4) as the efficacy data matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected; and (5) as a result of the foregoing, Clovis NDA was likely to be delayed and/or rejected by the FDA.

On May 6, 2016, Plaintiffs filed the Consolidated Class Action Complaint for Violations of the Federal Securities Laws and Jury Trial Demand (the "Consolidated Complaint").  Pursuant to the Court’s scheduling order, Defendants filed their motions to dismiss the Consolidated Complaint on July 27, 2016. Plaintiffs filed their opposition to Defendants’ motion to dismiss on September 23, 2016. Defendants’ reply briefs in support of dismissal were filed on October 14, 2016.

On February 9, 2017, the Court issued an Opinion and Order denying, in large part, Defendants’ motions to dismiss. The Court granted Plaintiffs fourteen days to file an Amended Consolidated Complaint and cure the identified deficiencies per the February 9, 2017 motion to dismiss order.  Accordingly, on February 13, 2017, Plaintiffs filed the Amended Consolidated Complaint.

On June 18, 2017, the parties agreed to a settlement of the litigation totaling approximately $142 million. On June 22, 2017, Plaintiffs filed a Notice of Motion and Unopposed Motion for Preliminary Approval of Class Action Settlement, which the Court granted on July 14, 2017 in its Order Preliminarily Approving Settlement and Providing for Notice. A hearing has been set for October 26, 2017 to address whether the settlement should receive final approval as fair, adequate and reasonable.

On June 18, 2017, the parties agreed to a settlement of the litigation totaling approximately $142 million. On June 22, 2017, Plaintiffs filed a Notice of Motion and Unopposed Motion for Preliminary Approval of Class Action Settlement, which the Court granted on July 14, 2017 in its Order Preliminarily Approving Settlement and Providing for Notice. A final approval settlement hearing was held on October 26, 2017 in which the Honorable Raymond P. Moore approved the settlement as fair, adequate and reasonable.