Alisertib

May 7, 2026 — Puma Biotechnology, Inc. (NASDAQ: PBYI) reported first-quarter 2026 financial results (ended March 31, 2026) and raised full-year 2026 revenue and net income guidance citing 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) a year earlier; non-GAAP adjusted net loss was $1.9M ($0.04/share) versus non-GAAP net income of $5.0M ($0.10/share). Operating cash flow improved to $15.4M (from $3.6M). Cash, cash equivalents and marketable securities were $101.5M at quarter-end; debt fell to $11.3M and the company stated it paid off remaining debt on May 4, 2026.

R&D expense rose to $19.8M (from $13.8M) primarily due to increased alisertib trial activity. Puma highlighted interim ALISCA™-Breast1 and ALISCA™-Lung1 Phase II data suggesting greater effect in biomarker subgroups and outlined enrollment expansions in H2 2026 and updated Breast1 data in Q4 2026. Full-year 2026 guidance increased to total revenue $222–$229M (from $214–$221M) and net income $16–$19M (from $10–$13M).