BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that it is investigating potential claims on behalf of investors of Puma Biotechnology, Inc. (“Puma” or the “Company”) (NYSE:PBYI) concerning possible violations of federal securities laws. The investigation focuses on certain statements issued by the Company concerning Puma’s operations and financial prospects.
Puma is a development stage biopharmaceutical company focused on the acquisition, development and commercialization of products to enhance cancer care. The Company’s drug candidates include PB272 (neratinib) for the treatment of advanced breast cancer patients.
The investigation is related to the Company’s December 2, 2014, announcement that its initial New Drug Application (NDA) filing with the U.S. Food and Drug Administration will now be for the early-stage breast cancer indication, and that Puma intends to delay its proposed timeline for filing its NDA until the first quarter of 2016.
Puma had previously communicated that it anticipated filing the NDA for PB272 in the first half of 2015, focused on the proposed clinical indication of metastatic breast cancer. According to the Company, based on its recent meetings with the FDA, “Puma will need to submit data from preclinical carcinogenicity studies with its NDA filing in accordance with International Conference on Harmonization guidelines.” Following this news, Puma shares declined approximately 12%, to a closing price of $197.67 per share on December 3, 2014, on heavy volume.
If you purchased Puma shares, if you have information or would like to learn more about these claims, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to firstname.lastname@example.org, or visit our website at www.howardsmithlaw.com.