ImmunityBio Inc. (NASDAQ: IBRX) completed enrollment of the full 366‑patient cohort in its Phase 2 randomized QUILT 2.005 trial on February 26 2026. The study compares ANKTIVA plus Bacillus Calmette‑Guérin (BCG) to BCG alone in patients with BCG‑naïve non‑muscle invasive bladder cancer (NMIBC). The enrollment milestone positions the company to file a biologics license application (BLA) with the U.S. Food and Drug Administration in the fourth quarter of 2026 and to pursue an expanded indication beyond the current BCG‑unresponsive setting.
The interim analysis, requested by the FDA, showed that 85 % of patients receiving ANKTIVA plus BCG maintained a complete response at six months versus 57 % for BCG alone, and 84 % maintained a complete response at nine months versus 52 % for BCG alone. The nine‑month data reached statistical significance with a p‑value of 0.0455, and no new safety signals were reported. These results suggest a durable benefit of the combination in a broader patient population.
ImmunityBio plans to submit a BLA in Q4 2026, which could open the drug to BCG‑naïve NMIBC patients and potentially increase the addressable market. The company’s management highlighted that the trial’s success could accelerate commercialization and support future revenue growth beyond the current BCG‑unresponsive indication.
Financially, ImmunityBio reported Q4 2025 revenue of $38.3 million and a net loss of $61.9 million. For the full year 2025, net product revenue reached $113 million, a 700 % year‑over‑year increase, while the net loss expanded to $351.4 million. The strong revenue growth reflects accelerating adoption of ANKTIVA, but the company continues to invest heavily in R&D and commercialization, contributing to the net loss and a negative Altman Z‑Score. Market reaction to the trial milestone was positive, with the stock trading near its 52‑week high and a 382 % year‑to‑date return.
Management commentary underscored the significance of the data. Dr. Christopher Pieczonka, Global Principal Investigator, said, "The interim results from this randomized study are encouraging and suggest that ANKTIVA plus BCG may improve the durability of response in patients with BCG‑naive NMIBC." Patrick Soon‑Shiong, Founder and Executive Chairman, added, "We are encouraged by these interim results and await the final unblinding of the completed trial. If approved, ANKTIVA plus BCG could offer a new treatment option earlier in the disease course for patients with NMIBC CIS, building on the therapy's existing approval in the BCG‑unresponsive setting." Richard Adcock, President and CEO, noted, "We delivered strong quarter‑over‑quarter revenue growth, reflecting accelerating adoption of ANKTIVA and the continued execution of our commercial strategy. This momentum is further reinforced by the approval of ANKTIVA plus BCG in Saudi Arabia, building on existing approvals in the U.S. and U.K, as well as conditional approval in the EU."
Analysts responded to the milestone with optimism. H.C. Wainwright raised its price target for ImmunityBio to $15 from $10, maintaining a Buy rating, while the consensus rating across analysts remained a Moderate Buy with an average price target of $12.60. The positive market reaction was driven by the combination of strong interim clinical data, robust commercial traction for ANKTIVA, and the prospect of a broader regulatory approval.
Additional context highlights the company’s broader strategy. ImmunityBio is addressing the ongoing BCG shortage through an Expanded Access Program for recombinant BCG, ensuring patient access to treatment. ANKTIVA is an IL‑15 superagonist that stimulates NK and T cells, synergizing with BCG to enhance anti‑tumor immunity. The drug is already approved in combination with BCG for BCG‑unresponsive NMIBC and is being pursued in other indications, including lung cancer and lymphopenia, with a regulatory footprint that now spans 33 countries. Competition includes Johnson & Johnson’s Inlexzo, underscoring the growing interest in immunotherapy for bladder cancer.
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