Puma Biotechnology Inc (NYSE: PBYI)
According to the law firm press release, Puma is a development stage biopharmaceutical company, focusing on the acquisition, development, and commercialization of products to enhance cancer care. The Company's 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 Company's 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 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.