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