Item 8.01 Other Events.

On February 20, 2013, Puma Biotechnology, Inc. (the "Company") issued a press release announcing that it had reached an agreement with the U.S. Food and Drug Administration under a Special Protocol Assessment for the planned Phase III clinical trial of the Company's lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior treatments (third-line disease). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

99.1 Press Release dated February 20, 2013

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