Puma Biotech Stock Surges 50% On Favorable FDA Release For Breast Cancer Drug

Puma Biotechnology Inc. shares surged 49.2% to $56.30 in morning trade Monday after the Food and Drug Administration released favorable briefing documents for an advisory committee meeting this week that will review Puma Biotech's breast cancer drug. The benefits of the drug, which addresses an unmet need after the standard of care second-line cancer therapy, outweigh its risks, according to the FDA briefing documents. The most common side side effect of the drug was diarrhea, with 95% of patients in clinical trials experiencing it, and 40% of patients experienced serious, or what's called grade 3, diarrhea, the documents said. The FDA's oncologic drugs advisory committee is scheduled to meet on Wednesday. Advisory committee recommendations are considered by the FDA when deciding whether to approve a drug. Puma Biotech shares have surged 64.6% over the last three months, compared with a 1.1% rise in the S&P 500 .

Copyright © 2017 MarketWatch, Inc.