Clinical Read2026-06-30

Alisertib - (PUMA-ALI-4201) - (ALISCA-Lung1)

Puma Biotechnology IncPBYI
Indication
Small Cell Lung Cancer (SCLC)
Stage
phase2
Event
Interim Data
Details

February 26, 2026: Puma Biotechnology, Inc. (NASDAQ: PBYI) reported Q4 and full-year 2025 financial results and provided 2026 guidance, while outlining upcoming clinical catalysts for alisertib.

Alisertib (Aurora kinase A inhibitor):

  • ALISCA™-Breast1 (Phase II; alisertib + endocrine treatment) in chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer: interim data presentation planned in Q2 2026; updated data presentation planned in Q4 2026.
  • ALI-4201/ALISCA™-Lung1 (Phase II; alisertib monotherapy) in extensive-stage small cell lung cancer: additional interim data presentation planned in Q2 2026.

Commercial product (NERLYNX®/neratinib): 2025 product revenue net was $204.1M (Q4 $59.9M). Total 2025 revenue was $228.4M including $24.3M royalty revenue.

2026 outlook: net product revenue $194–$198M; total revenue $214–$221M; net income $10–$13M (with Q1 2026 net loss projected at $(8)–$(10)M).

A conference call was scheduled for February 26, 2026 at 4:30 p.m. ET.