Puma leaps by 39% in anticipation of FDA panel's neratinib stance

Shares in USA-based Puma Biotechnology (NYSE: PBYI) closed 39% higher on Monday at $52.60 as investors sought to predict the position a US Food and Drug Administration (FDA) advisory panel would adopt on neratinib.

Puma submitted a New Drug Application (NDA) for the drug, which has been given the trade name Nerlynx, in July 2016 as a single agent indicated for the extended adjuvant treatment of adult patients with early stage ERBB2-positive breast cancer who have received prior adjuvant trastuzumab-based therapy.

The NDA includes the results of Study 3004, a multicenter, randomized, double-blind, placebo-controlled trial of one year of neratinib versus placebo in this patient group. The primary endpoint of the study was invasive disease-free survival (iDFS) within two years and 28 days.