Robbins LLP announces that an investor of Puma Biotechnology, Inc. (NYSE: PBYI) has filed a class action complaint in the United States District Court Central District of California. The complaint alleges that the company and certain of its officers and directors violated the Securities Exchange Act of 1934 between July 23, 2014 and May 13, 2015. Puma is a development stage biopharmaceutical companying that focuses on the acquisition, development, and commercialization of products to treat cancer.
Puma Biotechnology Accused of Overstating Results from Its Phase III ExteNET Trial
According to the complaint, defendants made materially false and misleading statements regarding the company’s lead product candidate PB272 (“neratinib”). On July 22, 2014, Puma issued a press release announcing that the results of a Phase III PB272 trial for the extended adjuvant treatment of breast cancer, known as the ExteNET trial, demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. Based on these results, Puma would file its New Drug Application (“NDA”) for regulatory approval of neratinib in the first half of 2015. However, according to the complaint, the press release misled investors by failing to address the company’s altered strategy for obtaining regulatory approval for neratinib and failing to properly describe the results of the trial.
Specifically, Puma changed its original strategy to file a New Drug Application with the U.S. Food and Drug Administration to apply neratinib for HER2-positive metastic breast cancer in favor of a plan to apply for extended adjuvant HER2-positive early stage breast cancer. This new strategy, according to the complaint, would require the submission of additional safety data the company lacked and delay its proposed timeline for filing the NDA from the first half of 2015 to the first quarter of 2016. After Puma announced its updated timeline for filing its NDA for approval of neratinib in the extended adjuvant treatment of HER2-positive early state breast cancer its stock plummeted $27.33 per share, or over 12%, to close at $197.67 per share on December 3, 2014.
Then, on May 14, 2015, shares of Puma fell an additional $39.05, or over 18.6%, to close at $170.67 per share, following the announcement that neratinib only performed 2.3% better than the placebo in the ExteNET trial, rather than the 33% previously indicated by the company on July 22, 2014.
Puma Shareholders Have Legal Options
Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Darnell R. Donahue at (800) 350-6003, or you can complete the form below and we will contact you directly.