Shares of Puma Biotechnology, Inc. (NASDAQ: PBYI) touched a multiyear high Tuesday after the company reported a key approval by the U.S. Food and Drug Administration (FDA). Specifically, the agency approved Nerlynx (neratinib), formerly known as PB272 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.

The bottom line here is that Puma expects neratinib to become commercially available in September 2017 and to be marketed as Nerlynx.

Shares of Puma were last trading up about 7% at $92.18 on the Nasdaq Stock Exchange, with a consensus analyst price target of $99.50 and a 52-week range of $28.35 to $97.15.

The FDA approval was based on the Phase 3 ExteNET trial of neratinib. The results of the ExteNET trial demonstrated that after two years of follow-up, invasive disease-free survival (iDFS) was 94.2% in patients treated with neratinib compared with 91.9% in those receiving placebo.

Marisa C. Weiss, M.D., chief medical officer and founder of breastcancer.org, commented:

The fear of recurrence is ever present in the minds of most women with breast cancer, from the moment they are diagnosed to long after they finish adjuvant treatment. New and effective innovative therapeutic options provide huge hope to patients and their families, giving them a better chance of overcoming breast cancer with a chance for a full life.

Alan H. Auerbach, chief executive officer and president of Puma, added:

Despite advances in the treatment of early stage HER2-positive breast cancer, there remains a need for further therapeutic improvements in order to attempt to further reduce the risk of disease recurrence. We are pleased to be able to bring this new medicine to patients with breast cancer.

 

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