SAN DIEGO, June 23, 2015 (GLOBE NEWSWIRE) -- The Shareholders Foundation, Inc. announces that a lawsuit was filed on behalf of certain purchasers of shares of Puma Biotechnology Inc (NYSE:PBYI) over alleged Violations of Federal Securities Laws by Puma Biotechnology Inc.
Investors who purchased shares of Puma Biotechnology Inc (NYSE:PBYI) have certain options and should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1 (858) 779-1554.
The plaintiff claims that between July 23, 2014 and May 13, 2015 defendants made allegedly false and/or misleading statements and/or allegedly failed to disclose that Puma Biotechnology’s NDA filing would be for a positive early stage breast cancer indication, instead of the previously announced metastatic breast cancer, that Puma Biotechnology would need to submit additional safety data from preclinical carcinogenicity studies with its NDA filing, which Puma did not have, that the additional required studies would necessarily push the timeline for filing the NDA into the first quarter of 2016, that Puma Biotechnology overstated results from its Phase III ExteNET Trial, and that 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 July 22, 2014, Puma Biotechnology Inc 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, it planned to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015. On December 2, 2014, Puma Biotechnology Inc announced that it intends to delay its proposed timeline for filing the new drug application (“NDA”) until the first quarter of 2016.
On May 13, 2015, Puma Biotechnology Inc released four abstracts for its PB272 (neratinib) breast cancer drug that were to be presented at the American Society of Clinical Oncology annual meeting.
The plaintiff claims that the modest difference of only 2.3% (p=0.0046) was lower than the market expected especially given that on July 22, 2014, Puma Biotechnology Inc stated that Neratinib performed 33% better than the placebo.
Those who purchased Puma Biotechnology Inc (NYSE:PBYI) shares have certain options and should contact the Shareholders Foundation, Inc. by e-mail at mail@shareholdersfoundation.com or call +1 (858) 779-1554.
The Shareholders Foundation, Inc. is a professional portfolio legal monitoring and a settlement claim filing service, which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. The Shareholders Foundation, Inc. is not a law firm. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.