Overview
- Following a Type B end-of-phase meeting, the FDA asked ImmunityBio to provide additional information to support resubmission of its supplemental BLA for papillary NMIBC and did not request new clinical trials.
- The company said it will deliver the requested materials within 30 days as it seeks to expand Anktiva’s use beyond its existing U.S. approval for carcinoma in situ.
- Published data from the QUILT-3.032 study reported 12-month disease-free survival of 58.2%, approximately 96% disease-specific survival at 36 months, and over 80% bladder preservation at three years.
- Commercial traction accelerated with preliminary 2025 net product revenue of about $113 million, and enrollment in the randomized BCG‑naïve registrational trial (QUILT‑2.005) surpassed 85% with full enrollment expected by the second quarter of 2026.
- Global expansion advanced with regulatory clearances in the U.K. and EU and Saudi approvals including accelerated authorization in metastatic lung cancer, while shares hit fresh 52‑week highs and an analyst raised the price target to $7 as early CAR‑NK signals remained preliminary.