NEW YORK, July 3, 2015 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Puma Biotechnology, Inc. ("Puma" or the "Company")(NYSE: PBYI) and certain of its officers. The class action, filed in United States District Court, Central District of California, and docketed under 15-cv-00865, is on behalf of a class consisting of all persons or entities who purchased Puma securities between July 23, 2014 and May 13, 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 Puma securities during the Class Period, you have until August 3, 2015 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, x237. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and number of shares purchased.
Puma is a development stage biopharmaceutical company, focusing on the acquisition, development, and commercialization of products to enhance cancer care. The Company's lead product candidate is an investigational drug known as PB272 ("neratinib"), which the Company had touted as an extended adjuvant treatment of human epidermal growth factor receptor 2 ("HER2")-positive metastatic breast cancer.
The Complaint alleges that throughout the Class Period, Defendants made false and/or 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: (1) the Company's NDA filing would be for a positive early stage breast cancer indication, instead of the previously announced metastatic breast cancer; (2) Puma would need to submit additional safety data from preclinical carcinogenicity studies with its NDA filing, which Puma did not have; (3) the additional required studies would necessarily push the timeline for filing the NDA into the first quarter of 2016; (4) the Company overstated results from its Phase III ExteNET Trial; and (5) as a result of the foregoing, Defendants lacked a reasonable basis for their positive statements about the Company and its outlook, including in its financial statements and about the ongoing ExteNET trial.
On December 2, 2014, the Company announced an update on the timeline for filing its New Drug Application (NDA) for the approval of PB272 (neratinib) in the extended adjuvant treatment of HER2-positive early stage breast cancer. While Puma had previously communicated that it anticipated filing the NDA for PB272 in the first half of 2015, including as recently as November 13, 2014, the December 2, 2014 announcement indicated that Puma intends to delay its proposed timeline for filing the NDA until the first quarter of 2016.
Thus, despite indicating that Puma would originally seek to apply neratinib for HER2-positive metastatic breast cancer, the Company secretly changed course and instead shocked the market by announcing plans to apply for extended adjuvant HER2-positive early stage breast cancer. However, this shift required additional safety data, which was unavailable to the Company.
On this news, shares of Puma fell $27.33 per share, or over 12%, to close at $197.67 per share on December 3, 2014 on extremely high volume.
On May 13, 2015, after the close of trading, Puma released four abstracts for its PB272 (neratinib) breast cancer drug that were to be presented at the American Society of Clinical Oncology ("ASCO") annual meeting.
From the presentation at the ASCO meeting, Abstract #508 provides a summary of the ExteNET trial which is a Phase 3 trial comparing Puma's lead product candidate, neratinib, to placebo in HER2+ breast cancer patients who were pre-treated with Roche's Herceptin (trastuzumab). The primary endpoint was the proportion of patients who were disease-free two years after adjuvant treatment as measured by invasive disease-free survival (IDFS). IDFS in the neratinib arm (n=1,409) was 93.9% compared to 91.6% for placebo (n=1,412). The modest difference of only 2.3% (p=0.0046) was lower than the market expected especially given that on July 22, 2014, the Company stated that Neratinib performed 33% better than the placebo.
On this news, shares of Puma fell $39.05 per share, or over 18.6%, to close at $170.67 per share on May 14, 2015, on unusually high 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
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