Overview
- Preliminary 2025 net product revenue reached about $113 million for Anktiva, with unit sales up roughly 750% and Q4 revenue of $38.3 million rising 20% sequentially and 431% year over year.
- Saudi regulators approved Anktiva with checkpoint inhibitors for metastatic non-small cell lung cancer and Anktiva plus BCG for BCG-unresponsive bladder cancer, adding to U.S., U.K., and conditional EU clearances for the bladder indication.
- Updated lung cancer data across 151 patients showed statistically significant immune restoration on Anktiva plus a checkpoint inhibitor and a consistent association between lymphocyte recovery and improved survival, with full details pending peer review.
- The randomized QUILT-2.005 trial in BCG-naïve NMIBC is over 85% enrolled, with full enrollment expected by Q2 2026 and a BLA submission planned by year-end 2026 after an interim analysis showed significantly longer duration of complete response versus BCG alone.
- Shares extended a multi-day surge on heavy volume, with coverage noting elevated short interest and intensified retail attention following the sales, clinical, and regulatory updates.