Puma Biotechnology (PBYI)

Puma Biotechnology, Inc. is a small cancer biotech whose only marketed product, Nerlynx (neratinib) was launched in the United Statesfor the treatment of early stage HER2-positive breast cancer in patients who have been previously treated with Roche's Herceptin-based adjuvant therapy. The drug was also approved in the European Union. Nerlynx in combination with Roche's Xeloda was approved'by the Food and Drug Administration for third-line HER2-positive metastatic breast cancer. Meanwhile, several additional studies on Nerlynx targeting different types of breast cancer patient populations as well as other types of cancers are currently underway. A key analysis of Nerlynx is the phase II SUMMIT basket study for treating solid tumors in patients with activating EGFR, HER2 or HER4 mutated cancers. Puma markets Nerlynx in the United States and has several sub-licenses in various regions outside the United States to commercialize Nerlynx in some international markets.