Overview
- Following a Type B end-of-phase meeting, the FDA asked ImmunityBio to file additional information to support resubmission of its papillary NMIBC sBLA without requiring new clinical studies.
- Updated QUILT data highlighted approximately 96% disease-specific survival at 36 months and cystectomy avoidance rates of 92% at one year and 82% at three years, with safety consistent with the current CIS indication.
- Enrollment in the randomized registrational QUILT-2.005 trial in BCG-naïve NMIBC is over 85% complete, with full enrollment anticipated by the second quarter of 2026.
- Preliminary 2025 net product revenue for Anktiva reached about $113 million, up roughly 700% year over year, and shares rose on heavy volume as investors reacted to the FDA feedback.
- Anktiva holds approvals in the U.S. for CIS, plus the U.K., conditional approval in the EU, and clearance in Saudi Arabia, where ImmunityBio plans commercial expansion through a local partner.