Puma Biotechnology Inc., of Los Angeles, said it will need to submit data from preclinical carcinogenicity studies with its new drug application (NDA) filing for PB272 (neratinib) in the extended adjuvant treatment of HER2-positive early stage breast cancer. Consequently, the company plans to delay the proposed timeline for filing the NDA from the first half of 2015 until the first quarter of 2016.