Alisertib

May 7, 2026 — Puma Biotechnology (NASDAQ: PBYI) reported first-quarter 2026 financial results and raised full-year 2026 guidance due to increased demand for NERLYNX (neratinib). Q1 2026 total revenue was $44.8M (NERLYNX net product revenue $42.0M; royalties $2.8M) versus $46.0M in Q1 2025. GAAP net loss was $3.8M ($0.07/share) versus GAAP net income of $3.0M ($0.06/share) in Q1 2025; non-GAAP adjusted net loss (excluding stock-based compensation) was $1.9M ($0.04/share) versus non-GAAP net income of $5.0M ($0.10/share). Operating cash flow improved to $15.4M (vs $3.6M), and cash/marketable securities were $101.5M at March 31, 2026; debt fell to $11.3M and was subsequently reduced to zero with final payment on May 4, 2026.

R&D expense increased to $19.8M (vs $13.8M) driven by higher alisertib trial activity. Puma cited interim ALISCA-Breast1 and ALISCA-Lung1 Phase II data suggesting stronger alisertib effects in certain biomarker subgroups, with planned enrollment expansions (H2 2026) and updated data presentation (Q4 2026). Full-year 2026 total revenue guidance increased to $222–$229M (from $214–$221M) and net income to $16–$19M (from $10–$13M).