The Complaint brought forth claims for violations of the Securities Exchange Act of 1934 against Clovis Oncology, Inc. (“Clovis” or the “Company”), and certain of its senior executives. The Complaint alleged that Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects on behalf of all persons or entities that purchased or otherwise acquired Clovis securities during the Class Period, including those who purchased Clovis common stock pursuant to Clovis’ Secondary Offering.
Clovis is a pharmaceutical company that developed a proprietary cancer drug called rociletinib.
Specifically, the Complaint alleged 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. At the time of the drug’s development, Clovis was also facing still competition from a pharmaceutical giant Astra-Zeneca that was producing a similar experimental drug called Tagrisso, to treat the same class of patients targeted by Clovis.
On February 9, 2017, the Court denied, in large part, Defendants’ motions to dismiss. The Court also granted Plaintiffs an opportunity to file an Amended Consolidated Complaint to cure identified deficiencies in the Court’s order. Plaintiffs filed the Amended Consolidated Complaint on February 22, 2017.
On June 18, 2017, the parties agreed to a settlement of the litigation totaling approximately $142,000,000 for the benefit of the Settlement Class. On July 14, 2017, the Court preliminarily approved the settlement, and then on October 26, 2017, entered final judgment finding the settlement to be fair, adequate and reasonable in all respects.