Puma Biotechnology Updates Timeline For Filing New Drug Application

Puma Biotechnology, Inc.

, a development stage biopharmaceutical company, today provided an update on the timeline for filing its New Drug Application (NDA) for the approval of PB272 (neratinib) in the extended adjuvant treatment of HER2-positive early stage breast cancer. Puma had previously communicated that it anticipated filing the NDA for PB272 in the first half of 2015. This was based on the feedback it had previously received from regulatory agencies, which had been focused on the proposed clinical indication of HER2-positive metastatic breast cancer. Since the Company's initial NDA filing will now be for the extended adjuvant HER2-positive early stage breast cancer indication, based on the company's recent meetings with the U.S. Food and Drug Administration (FDA), Puma will need to submit data from preclinical carcinogenicity studies with its NDA filing in accordance with International Conference on Harmonization (ICH) guidelines. In order to accommodate this requirement, Puma intends to delay its proposed timeline for filing the NDA until the first quarter of 2016.