Puma Biotechnology reports Q2 adjusted EPS ($1.38), consensus ($2.04)
"During the second quarter of 2017, we achieved a significant milestone for Puma with the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee meeting, which led to last month's FDA approval of NERLYNX for the extended adjuvant treatment of HER2-positive early stage breast cancer. This marked a major milestone for breast cancer patients and for Puma," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Despite advances in early stage HER2-positive breast cancer treatment, there continues to be a need to reduce the risk of disease recurrence. NERLYNX has been demonstrated to significantly reduce that risk and offers physicians and their patients another treatment option. NERLYNX is now commercially available by prescription in the United States. We are also working with the European Medicines Agency on their review of our marketing authorization application for this indication and we expect the Committee for Medicinal Products for Human Use, the scientific committee of the EMA, to issue an opinion regarding the MAA for neratinib in the first quarter of 2018."