ImmunityBio, Inc. (IBRX) announced that it has made progress in regulatory discussions with the FDA regarding a potential resubmission of its supplemental Biologics License Application (sBLA) for ANKTIVA (nogapendekin alfa inbakicept) in patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors.
BGC-unresponsive papillary NMIBC is a serious condition where the standard of care often involves radical cystectomy, a surgery to remove the bladder that carries significant risks and quality-of-life impacts. Currently, no targeted therapies are approved for this patient population.
ANKTIVA is an IL-15 agonist fusion protein designed to activate natural killer (NK) cells and CD8+ T cells, enhancing the immune system's ability to fight cancer.
It is already approved in the U.S. for NMIBC carcinoma in situ (CIS) with or without papillary tumors, and has received approvals in the United Kingdom, Saudi Arabia, and conditional approval in the European Union.
Last May, the FDA issued a Refusal to File (RTF) letter for the company's supplemental biologics license application (sBLA) for use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease. T
Today, the company revealed that the FDA has sought additional information to be provided within 30 days to support a resubmission of its sBLA for papillary NMIBC. Importantly, the agency did not request new clinical trials. Following a recent Type B End-of-Phase meeting with the FDA, the company plans to submit the requested data package promptly.
Long-term results from the QUILT-3.032 Phase 2/3 trial in 80 patients with BCG-unresponsive papillary NMIBC demonstrated durable outcomes:
•96% bladder cancer-specific survival at 36 months.
•Over 80% bladder preservation at three years.
•Cystectomy-free survival of 92% at one year and 82% at three years.
These results underscore ANKTIVA's potential as a bladder-sparing alternative to surgery, offering patients a chemo-free immunotherapy option.
ImmunityBio also highlighted that its first-line BCG-naïve NMIBC program is advancing rapidly, with enrolment exceeding expectations and positive interim analysis showing promise for ANKTIVA plus BCG in newly diagnosed patients.
This regulatory progress represents a significant step toward expanding ANKTIVA's label to include papillary-only NMIBC, potentially transforming treatment for patients who currently face limited options.
We alerted our readers on January 16, 2026, when the stock was trading at $3.95
IBRX has traded between $1.83 and $5.58 over the past year. The stock closed January 16, 2025, trading at $5.52, up 39.75% and rose further in today's pre-market trading to $6.65, up 20.74%, touching a new 52-week high.
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