Puma Biotechnology Inc

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Case Summary
Company Name: Puma Biotechnology Inc
Stock Symbol : (NYSE: PBYI)
Class Period Start: 07/23/2014
Class Period End: 05/13/2015
Lead Plaintiff motion: 08/03/2015
Date Filed: 06/03/2015
Type of Case: Securities Class Action
Court: U.S. District Court for the District of California
Summary:

Thieler Law Corp advises investors with losses exceeding $100,000 of the August 3, 2015 lead plaintiff deadline in a class action lawsuit filed against Puma Biotechnology Inc (NYSE: PBYI) (“Puma Bio” or “the Company”). The suit is pending in the U.S. District Court for the District of California and investors, who purchased Puma Bio securities between July 23, 2014 and May 13, 2015, have until August 3, 2015 to move for lead plaintiff. You do not need to move for lead plaintiff to be a member of the Class.

If you purchased Puma Bio securities during the Class Period, and have losses over $100,000, you may contact Thieler Law Corp by calling at (619) 866-6157 or emailing mail@thielerlaw.com.  No class has been certified in this case, and if your losses are less than $100,000 you are still a member of the class.

The complaint alleges that during the Class Period defendants made false and misleading statements and/or allegedly failed to disclose that: (1) Puma Bio’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 Bio would have to submit additional safety data from preclinical carcinogenicity studies with its NDA filing, which the Company lacked; (3) the additional required studies would forcibly move the submission of the filing of the NDA to the first quarter of 2016; (4) the Company overstated results from its Phase III ExteNET Trial; and (5) as a result of the these disclosures, Puma Bio did not have any grounding for their positive statements about the Company and its outlook, including in its financial statements and about the ongoing ExteNET trial.

On July 22, 2014, Puma Bio announced positive top line results from the Phase III clinical trial of Puma's investigational breast cancer drug, PB272 (neratinib). Puma Biotechnology Inc said that based on the results from the ExteNET study, Puma plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015. PBYI stock went up from $59.03 per share on July 22, 2014, to $233.43 per share on July 23, 2014 and continued gaining value to as high as $275.07 per share in September 2014.

On December 2, 2014, Puma Bio announced that it had to extend  its proposed timeline for filing the new drug application into the first quarter of 2016. Puma Bio said that it originally focused on the proposed clinical indication of HER2-positive metastatic breast cancer and now plans to apply first for extended adjuvant HER2-positive early stage breast cancer.  PBYI stock dropped from $228.82 per share on December 2, 2014, to $189.51 per share on December 3, 2014.

On May 13, 2015, after the close of trading, Puma Bio released four abstracts for its PB272 (neratinib) breast cancer drug that were to be presented at the American Society of Clinical Oncology annual meeting. From the presentation at the American Society of Clinical Oncology meeting, Abstract #508 provides a summary of the ExteNET trial which is a Phase 3 trial comparing Puma Biotechnology Inc'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 complaint alleges that the small difference of only 2.3% (p=0.0046) was lower than market expectations especially given that on July 22, 2014, Puma Bio stated that Neratinib performed 33% better than the placebo.

If you were negatively impacted by your investment in Puma Bio securities between July 23, 2014 and May 13, 2015 and would like to learn more about this lawsuit and your ability to participate as a lead plaintiff, please contact us for your no-cost evaluation.

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Please find below an excerpt of the complaint filed

Puma Biotechnology Inc Complaint 2015

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