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Gainey McKenna & Egleston Announces a Class Action Lawsuit Has Been Filed Against Puma Biotechnology, Inc. (PBYI)

20:00 EDT 2 Jun 2015 | Globe Newswire

NEW YORK, June 03, 2015 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed in the United States District Court for the Central District of California on behalf of all persons or entities who purchased Puma Biotechnology, Inc. (“Puma” or the “Company”) (NYSE:PBYI) securities between July 23, 2014 and May 13, 2015, inclusive (“Class Period”).

The Complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that:  (1) the Company’s New Drug Application (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 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 Complaint alleges that 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.

If you wish to serve as lead plaintiff, you must move the Court no later than August 3, 2015.  A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.  If you wish to join the litigation, or to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.

Attorney Advertising -- Prior results do not guarantee a similar outcome with respect to any future matter.  Please visit our website at http://www.gme-law.com for more information about the firm.

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