Puma Biotech Wins Big on FDA Approval of Breast Cancer Treatment

By Chris Lange Updated Jan 12, 10:02AM EST · Published Jul 18, 11:31AM EDT

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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.

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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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About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.