In December 2025, immunotherapy firm ImmunityBio received a conditional marketing authorization recommendation from the European Medicines Agency for its drug ANKTIVA. The recommendation is for using the drug in combination with the BCG vaccine to treat BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. It represents the first immunotherapy for this indication to receive positive EMA assessment in Europe.
The Culver City, California-based biotechnology company reported third-quarter 2025 product revenue of $31.8 million, a 434% increase compared to the prior-year period, while year-to-date product sales reached $74.7 million. Hedge funds including Armistice Capital, Alphacore, and Geode Capital acquired positions in ImmunityBio in 2025, establishing some of the largest stakes in the commercial-stage immunotherapy company.
Clinical Results Drive Regulatory Progress
The QUILT-3.032 study enrolled 100 patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ who received ANKTIVA in combination with BCG. Results showed a 71% complete response rate with responses extending to 54 months and ongoing, exceeding duration of response benchmarks for approved products in the indication.
Data presented at the 2025 American Urological Association Annual Meeting demonstrated that 96%, 90%, and 84% of patients remained cystectomy-free at 12, 24, and 36 months, respectively. Disease-free survival rates reached 100%, 99%, and 99% at those same timepoints.
ANKTIVA (nogapendekin alfa inbakicept) functions as an interleukin-15 receptor agonist that stimulates CD4+ and CD8+ T cells alongside natural killer cells to enhance immune responses. The therapy received FDA approval in April 2024 for BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ with or without papillary tumors, and secured UK approval in July 2025.
European Market Opportunity
Bladder cancer is the fifth-most common cancer in the European Union and the seventh most frequently diagnosed cancer among men. The European Association of Urology and World Bladder Cancer Patient Coalition estimated approximately 200,000 patients received bladder cancer diagnoses in 2025, with roughly 75% classified as non-muscle invasive disease.
“ANKTIVA offers a new treatment option for patients and addresses an important unmet need,” the EMA noted. “There are currently no authorised treatments for NMIBC that does not respond to BCG.”
Richard Adcock, President and CEO of ImmunityBio, stated the company is “looking forward to finalizing plans to bring our innovative treatment to qualified EU patients,” while noting the company is “thoughtfully assessing our approach to launching in Europe to ensure broad, equitable, and sustainable access” given U.S. prescription drug pricing policy changes.
Europe offers access to six approved BCG substrains for combination therapy with ANKTIVA, compared to one substrain available in the United States. ImmunityBio is developing a recombinant BCG candidate to address ongoing BCG shortages domestically.
Third-Quarter Financial Performance
ImmunityBio reported third-quarter 2025 revenue totaling $32.06 million against analyst estimates of $31.88 million.
Unit sales growth reached 467% year-to-date through the third quarter, driven by ANKTIVA adoption in the United States following FDA approval.
Institutional Investment Activity
Several institutional investors established or expanded positions in ImmunityBio during the second quarter of 2025. In addition to Armistice Capital, Geode Capital, and AlphaCore Capital, major institutional holders include Vanguard Group, BlackRock, State Street, and Jane Street Group. Institutional investors collectively own approximately 8.58% of the company’s outstanding shares according to recent filings.
The company’s market capitalization stood at approximately $2.05 billion in early January 2026, with shares trading in a 52-week range of $1.83 to $4.27.
ImmunityBio continues advancing its clinical pipeline beyond bladder cancer, including Phase 2 studies in non-small cell lung cancer and combination therapy trials for glioblastoma. The company is awaiting European Commission final approval for ANKTIVA, anticipated in early 2026.
Follow our WhatsApp channel
