ImmunityBio stock jumps 35% as ANKTIVA bladder cancer trial update puts FDA filing in view

ImmunityBio stock jumps 35% as ANKTIVA bladder cancer trial update puts FDA filing in view

New York, Jan 16, 2026, 12:51 PM EST — Regular session

ImmunityBio (IBRX.O) shares jumped about 35% on Friday after the cancer drugmaker reported faster enrollment and stronger interim results in a key bladder cancer study for its ANKTIVA therapy. The stock was up $1.39 at $5.34 by 12:51 p.m. EST after hitting $5.53, with about 133 million shares traded. The company said more than 85% of patients are enrolled in its QUILT-2.005 trial and it is targeting a U.S. filing by the end of 2026; an interim analysis showed 85% of patients on ANKTIVA plus BCG stayed in complete response at six months versus 57% on BCG alone and 84% versus 52% at nine months (p=0.0455). (ImmunityBio)

The move matters because the bet here is not just another data point — it’s whether ANKTIVA can move earlier in treatment, where patient numbers are bigger and doctors have more choices. BCG, short for Bacillus Calmette-Guérin, is a vaccine-based therapy doctors deliver into the bladder; “BCG-naïve” patients simply haven’t received it before.

ImmunityBio’s timeline also gives traders something to anchor on. A biologics license application, or BLA, is the FDA’s marketing-approval package for biologic drugs, and the company is trying to line up its next label push around enrollment pace and durability — not a one-off headline.

On Thursday, ImmunityBio disclosed preliminary, unaudited net product revenue of about $113 million for 2025 and about $38.3 million in the fourth quarter, topping the prior quarter’s $31.8 million. It also said it ended 2025 with an estimated $242.8 million in cash, cash equivalents and marketable securities, and CEO Richard Adcock said the quarter showed “accelerating adoption of ANKTIVA,” while founder Patrick Soon‑Shiong pointed to Saudi approvals as “the world’s first approval of an IL-15 superagonist” used with checkpoint therapy. (Business Wire)

Saudi regulators granted accelerated approval for ANKTIVA in combination with immune checkpoint inhibitors for metastatic non-small cell lung cancer in adults whose disease progressed after standard treatment, the company said on Wednesday. ImmunityBio said it would work with distributor Biopharma Cigalah and plans a regional office in the kingdom; Soon‑Shiong called the decision “a meaningful milestone” for patients in Saudi Arabia. (Business Wire)

ImmunityBio on Friday also released early data from its QUILT-106 study of an off-the-shelf CD19 CAR-NK cell therapy — engineered natural killer immune cells designed to target cancer — in Waldenström lymphoma, a rare B-cell malignancy. The company said two evaluable patients showed complete responses lasting seven and 15 months and that all four treated patients remained under disease control; chief medical officer Lennie Sender said patients were treated as outpatients with “no serious adverse events.” (Business Wire)

The market is stitching those pieces together: a commercial product with growing sales, more shots on goal in other cancers, and a clinical program that could widen the front end of the bladder-cancer funnel. It’s the kind of setup that can move a small-cap biotech stock fast, both ways.

But interim reads can soften with longer follow-up, and small patient numbers can make early gaps look bigger than they end up being. The FDA filing and approval path is still a target, not a done deal, and the revenue figures the company cited this week are preliminary and could shift when the audit work is finished.

Next up, investors will watch for final enrollment in QUILT-2.005 by the second quarter of 2026 and for more detail when the company files its full-year 2025 results. The hard catalyst on the horizon is still the same one ImmunityBio put down in black and white: a planned BLA submission to the FDA by the end of 2026.

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