PBYI News & Events

Reports Q4 revenue $75.5M vs. $59.1M last year. "Our financial performance in the fourth quarter and full year 2025 demonstrates continued momentum, with net income marking our third consecutive year of profitability, a testament to our disciplined execution and careful fiscal stewardship," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our current guidance forecasts that we will continue to be profitable in 2026, which we believe is a result of this continued financial discipline. In parallel, we continue to advance alisertib clinically through ALISCA(TM)-Breast1 and ALISCA(TM)-Lung1, targeting patient populations in chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer and extensive-stage small cell lung cancer."

Sees FY26 revenue $214M-$221M, one estimates $220M.

Reports Q3 revenue $54.5M, one estimate $51.0M. "We are very happy to report the continuation of our positive earnings trend, which is driven by increased demand for NERLYNX(R)," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "According to our current projections, 2025 will mark the first year-over-year demand increase for NERLYNX in the United States since 2018 and we are very pleased with our commercial execution, which contributed to this. We are also pleased with our continued clinical progress in the advancement of alisertib for patients facing chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer in ALISCATM-Breast1 and for patients with extensive-stage small cell lung cancer in ALISCATM-Lung1, where there continues to be a need for new treatment. We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA(TM)-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer (H1 2026) and (ii) presentation of additional interim data from the ALI-4201/ALISCA(TM)-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H1 2026)."

Reports Q revenue $54.5M, one estimate $51.0M. "We are very happy to report the continuation of our positive earnings trend, which is driven by increased demand for NERLYNX(R)," said Alan H. Auerbach, Chairman, Chief Executive Officer, and President of Puma. "According to our current projections, 2025 will mark the first year-over-year demand increase for NERLYNX in the United States since 2018 and we are very pleased with our commercial execution, which contributed to this. We are also pleased with our continued clinical progress in the advancement of alisertib for patients facing chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer in ALISCATM-Breast1 and for patients with extensive-stage small cell lung cancer in ALISCATM-Lung1, where there continues to be a need for new treatment. We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from ALISCA(TM)-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer (H1 2026) and (ii) presentation of additional interim data from the ALI-4201/ALISCA(TM)-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H1 2026)."