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Shareholder Class Action Filed Against Puma Biotechnology, Inc.

Notice is hereby given that a class action lawsuit has been filed on behalf of those who purchased or otherwise acquired shares of Puma Biotechnology, Inc. (NYSE: PBYI) (“Puma”) between February 27, 2014 and May 4, 2015, inclusive (the “Class Period”).  

Puma Biotechnology, Inc. investors may receive additional information about the case by clicking the link "Join this Class Action" above.

According to the complaint, Puma is  a  development  stage  biopharmaceutical  company,  focusing  on  the acquisition, development, and commercialization of products to enhance  cancer care. The Companys 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  Companys  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 Companys 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.

If you are a member of the class described above, you may no later than August 3, 2015, move the Court to serve as lead plaintiff of the class, if you so choose.

A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation.  In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class.  Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of their choice, or may choose to do nothing and remain an inactive class member.

Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP.


Kessler Topaz Meltzer & Check, LLP
James Maro, Esq.
Adrienne Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087
1-888-299-7706 (toll free) or 1-610-667-7706

Please list your purchase and sale transaction(s) in the Puma Biotechnology, Inc. security that is subject of this action during the Class Period (between February 27, 2014 and May 4, 2015):

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# of Shares
Price per Share
Principal Amount
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# of Contracts
Price per Contract
Exercise Price
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Did you purchase shares of Puma Biotechnology, Inc. prior to the Class Period?
Are you a current or former employee of Puma Biotechnology, Inc.?
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