Puma Biotechnology (PBYI) shares have surged in pre-market trading today after the company announced the filing of its New Drug Application (NDA) with the FDA seeking approval of lead product candidate neratinib (PB272) for the extended adjuvant treatment of patients with HER2-overexpressed/amplified breast cancer who received prior adjuvant treatment with Roche’s (RHHBY). The company filed its Marketing Authorization Application (MAA) in Europe last month.