Puma Biotechnology raises 2026 guidance on NERLYNX demand, details alisertib trial timeline

Puma Biotechnology reported financial results for the quarter ended June 30, 2026 on August 6, 2026, alongside an update on its clinical pipeline. Chief Executive Alan H. Auerbach said the company remains focused on continuing commercial execution in the second half of the year and on advancing alisertib in the ALISCA clinical trials in HER2-negative, hormone receptor-positive metastatic breast cancer and small cell lung cancer.¹

Auerbach laid out specific milestones expected over the next 12 months: enrollment is set to begin in ALISCA-Lung2, a Phase I/II trial of alisertib combined with paclitaxel for extensive stage small cell lung cancer, in the third quarter of 2026; enrollment will expand in ALISCA-Breast1, a Phase II trial of alisertib with endocrine treatment in chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer, in the second half of 2026; ALISCA-Lung1, a Phase II monotherapy trial in extensive-stage small cell lung cancer, will also expand enrollment in the second half of 2026; and updated ALISCA-Breast1 data are expected to be presented in the fourth quarter of 2026.¹

On finances, Puma raised its full-year 2026 outlook. The company now projects net product revenue of $205 to $209 million and total revenue of $224 to $231 million for full year 2026, up from a prior forecast of $202 to $206 million in net product revenue and $222 to $229 million in total revenue, with net income guidance raised to $17 to $20 million from $16 to $19 million.¹

On its balance sheet, Puma said that on May 4, 2026, it paid off the remaining principal, interest and exit fees owed under its 2021 Note Purchase Agreement, bringing outstanding debt to zero and ending the related obligations except for standard indemnification terms.¹ As of June 30, 2026, Puma held cash, cash equivalents and marketable securities of $93.9 million, compared to $97.5 million at December 31, 2025.¹