What This Recent FDA Move Could Mean for Breast Cancer Patients With Brain Metastases

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Puma Biotechnology Inc. (NASDAQ: PBYI) shares jumped early Wednesday after the announcement that the U.S. Food and Drug Administration (FDA) provided an update on the company’s breast cancer treatment. However, this seems to be a case of sell the news, as Puma quickly fell off from this FDA sugar high.

Specifically, the FDA granted Orphan Drug Designation to Nerlynx (neratinib) for the treatment of breast cancer patients with brain metastases.

The FDA Orphan Drug Designation program grants orphan designation to investigational drugs designed to treat, prevent or diagnose rare medical diseases or conditions that affect fewer than 200,000 individuals in the United States.

Also, the designation qualifies sponsors for several key benefits and incentives, including opportunities for grant funding towards clinical trial costs, tax credits, user fee waivers and the potential for a seven-year period of marketing exclusivity upon FDA approval of the investigational drug for the indication for which it has orphan designation.

Alan H. Auerbach, board chair, chief executive and president of Puma, commented:

Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer. Despite expanded treatment options for HER2-positive breast cancer, brain metastases in these patients represent a significant clinical challenge, as well as sources of morbidity and mortality for most of these patients. The blood-tumor penetrability of NERLYNX represents a potential treatment option for these underserved patients.

Shares of Puma Biotech traded down about 1.5% to $10.25 on Wednesday, after having been up as much as 10% in the premarket. The stock has a consensus price target of $21.14 and a 52-week trading range of $8.45 to $50.75.


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