Puma Biotechnology reports Q3 EPS 17c, consensus 8c

Reports Q3 revenue $56.1M, two estimates $58.0M. “We are pleased to report both positive net income and positive cash flow for the third quarter of 2023,” said Alan H. Auerbach, CEO. “In addition, we were pleased to report the FDA’s acceptance of our IND for alisertib and their granting of Orphan Drug Designation to alisertib for the treatment of small cell lung cancer, and we look forward to advancing the clinical development of alisertib in this indication. We anticipate the following key milestones over the next 12 months: (i) initiating a Phase II clinical trial of alisertib in small cell lung cancer (Q4 2023); (ii) conducting a meeting with the FDA to discuss the clinical development and registration pathway for alisertib in hormone receptor positive, HER2-negative breast cancer (Q4 2023); and (iii) initiating a Phase II clinical trial of alisertib in hormone receptor positive, HER2-negative breast cancer (2024).”