The Shareholders Foundation announces that an investor in shares of Puma Biotechnology Inc (NYSE:PBYI) filed a lawsuit in the U.S. District Court for the Central District of California over alleged violations of Federal Securities Laws by Puma Biotechnology Inc in connection with certain allegedly false and misleading statements.
Investors who purchased shares of Puma Biotechnology Inc (NYSE:PBYI) have certain options and for certain investors are short and strict deadlines running. Deadline: August 3, 2015. NYSE:PBYI investors should contact the Shareholders Foundation at mail@shareholdersfoundation or call +1(858) 779 – 1554.
According to the complaint the plaintiff alleges on behalf of purchasers of Puma Biotechnology Inc (NYSE:PBYI) common shares between July 23, 2014 and May 13, 2015, that the defendants violated Federal Securities Laws. More specifically, 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: (1) the Company’s 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 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, Puma plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015. Shares of Puma Biotechnology Inc (NYSE:PBYI) jumped from $59.03 per share on July 22, 2014, to $233.43 per share on July 23, 2014 and continued to increase to as high as $275.07 per share in September 2014.
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. Puma Biotechnology Inc 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. Share of Puma Biotechnology Inc (NYSE:PBYI) declined 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 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. 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 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.
Shares of Puma Biotechnology Inc (NYSE:PBYI) declined to as low as $115.58 per share on June 26, 2015.
Those who purchased shares of Puma Biotechnology Inc (NYSE:PBYI) have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North – Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com