NEW YORK, Jan. 8, 2016 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Clovis Oncology, Inc. ("Clovis" or the "Company") (NASDAQ: CLVS) and certain of its officers. The class action, filed in United States District Court, District of Colorado, and docketed under 15-cv-02697 is on behalf of a class consisting of all persons or entities who purchased Clovis securities between October 31, 2013 and November 15, 2015 inclusive (the "Class Period"). This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934 (the "Exchange Act").
If you are a shareholder who purchased Clovis securities during the Class Period, you have until January 19, 2016 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll free, ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and number of shares purchased.
Clovis is a biopharmaceutical company that focuses on acquiring, developing, and commercializing innovative anti-cancer agents in the United States, Europe and additional international markets.
The Complaint alleges that throughout the Class Period, Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants made false and/or 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 set 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; (5) as a result of the foregoing, Clovis' NDA was likely to be delayed and/or rejected by the FDA; and (6) as a result of the foregoing, the Defendants' statements about Clovis' business, operations, and prospects, were false and misleading and/or lacked a reasonable basis.
On November 16, 2015, Clovis issued a press release disclosing that the U.S. Food and Drug Administration ("FDA") requested additional clinical data after the efficacy of one of the Company's drugs, rociletinib (or "CO-1686"), was thrown into doubt. Specifically, the Company disclosed that the FDA requested additional clinical data for use in the efficacy analysis for both the 500mg and 625mg BID dose patient groups for rociletinib, and that "as the rociletinib clinical trials were rapidly enrolling, Clovis presented interim data publicly and at medical meetings and this data therefore included a data set based primarily on unconfirmed responses. This was also true of the Company's Breakthrough Therapy designation submission. In the Company's NDA submission, both immature confirmed and unconfirmed response analyses were submitted. As the efficacy data have matured, the number of patients with an unconfirmed response who converted to a confirmed response was lower than expected."
On this news, shares of Clovis fell $69.19 per share, or nearly 70%, to close at $30.24 on November 16, 2015, on unusually heavy trading volume.
The Pomerantz Firm, with offices in New York, Chicago, Florida, and Los Angeles, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 70 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
SOURCE Pomerantz LLP