Shares of ImmunityBio Inc. rose sharply midday Thursday as the commercial-stage immunotherapy company reported record preliminary first-quarter 2026 net product revenue of approximately $44.2 million from its flagship bladder cancer therapy ANKTIVA, marking a 168% increase from the same period last year and underscoring accelerating commercial traction despite a recent FDA warning on promotional materials.

ImmunityBio
ImmunityBio

At 1:16 p.m. EDT on April 9, ImmunityBio (NASDAQ: IBRX) traded at $7.46, up 49 cents or 6.95%, according to real-time market data. The gain came on solid volume as investors reacted positively to the revenue update released earlier in the day, which also showed the company ending the quarter with an estimated $380.9 million in cash, cash equivalents and marketable securities.

The preliminary results highlighted continued quarter-over-quarter and year-over-year growth for ANKTIVA (nogapendekin alfa inbakicept-pmln), the company's IL-15 superagonist approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. Net product revenue grew 15% sequentially from $38.3 million in the fourth quarter of 2025 and built on full-year 2025 revenue of $113 million — a roughly 700% jump from 2024.

CEO Richard Adcock and Executive Chairman Patrick Soon-Shiong have emphasized ANKTIVA's role in ImmunityBio's broader immunotherapy platform, which combines cytokines, vaccines and cellular therapies. The drug is now approved or under review in multiple jurisdictions, including conditional approvals in the European Union and Saudi Arabia, with submissions planned for additional markets in 2026.

The revenue surge provided a timely boost after a volatile period. In late March, shares dropped sharply following an FDA warning letter from the Office of Prescription Drug Promotion concerning a television advertisement and podcast that the agency deemed false or misleading. The materials allegedly overstated ANKTIVA's benefits, creating the impression it could cure or prevent cancer more broadly than its approved indication.

ImmunityBio responded swiftly. On April 6, the company announced it had submitted a comprehensive reply to the FDA, removed the cited podcast from platforms, confirmed the TV ad was never aired, and initiated a broad review of promotional materials with enhanced compliance protocols. Analysts, including those at BTIG who maintained a Buy rating with a $13 price target, viewed the matter as resolvable and not materially impacting the underlying commercial momentum.

Despite the promotional setback, ANKTIVA has gained traction in clinical guidelines. The National Comprehensive Cancer Network (NCCN) updated its 2026 bladder cancer guidelines to include the therapy in additional settings, supporting broader adoption. Long-term data from the QUILT-3.032 trial continue to show durable responses, with some patients maintaining complete responses beyond 53 months.

Pipeline progress remains a key focus. ImmunityBio confirmed in late March that its pivotal randomized QUILT-2.005 trial evaluating ANKTIVA plus BCG versus BCG alone in BCG-naïve NMIBC patients is adequately powered, with enrollment completed ahead of schedule in February. A supplemental Biologics License Application (sBLA) for BCG-naïve indications is on track for submission in the fourth quarter of 2026. The company also resubmitted an sBLA for papillary-only disease following FDA feedback.

Additional milestones include ongoing trials in non-small cell lung cancer (NSCLC), where Saudi Arabia granted conditional accelerated approval for ANKTIVA in combination with checkpoint inhibitors. Plans call for further ex-U.S. submissions and discussions with the FDA regarding accelerated pathways. Early-stage programs in CAR-NK cell therapies and recombinant BCG are also advancing, with an expanded access program for recombinant BCG enrolling hundreds of patients.

Financially, the company strengthened its balance sheet in early April with $100 million in financing transactions, including $75 million in non-dilutive funding to support global expansion and pipeline advancement. Cash reserves provide runway as ANKTIVA sales scale and new indications are pursued.

Wall Street sentiment leans constructive. Consensus ratings hover near Strong Buy, with average price targets around $14 to $15, implying significant upside from current levels. Analysts project continued revenue growth in 2026 driven by ANKTIVA uptake, repeat dosing (up to 36 doses over 37 months per label) and international launches. Risks include execution on commercial scaling, regulatory outcomes and competition in the immunotherapy space.

The stock has exhibited high volatility typical of clinical-stage and early-commercial biotech names. After a strong run earlier in 2026 fueled by regulatory wins and revenue beats, shares pulled back on the FDA letter before stabilizing. Thursday's advance reflects renewed confidence in the commercial story amid a broader market tone supported by easing geopolitical concerns.

ImmunityBio's approach centers on orchestrating the immune system through multiple platforms rather than single-target therapies. Executives highlight the potential for durable complete responses across tumor types, with ongoing studies in lung cancer, lymphoma and other indications.

For patients with BCG-unresponsive NMIBC, ANKTIVA offers an alternative to cystectomy, with real-world data showing high bladder preservation rates. The company continues to invest in manufacturing and distribution to meet growing demand.

As the first quarter closed, ImmunityBio appeared to be transitioning successfully from development to commercialization while advancing a robust pipeline. The record revenue figure underscores that momentum, even as the company navigates regulatory scrutiny on marketing practices.

Looking ahead, investors will watch for the full first-quarter report and any updates on the papillary sBLA review timeline. Positive data readouts from the BCG-naïve trial or new international approvals could provide further catalysts.

Thursday's gain positions ImmunityBio as one of the stronger performers in the biotech sector amid a session marked by mixed results elsewhere. Whether the rally sustains will depend on sustained commercial execution and clear communication with regulators.

For a company once known primarily for its ambitious science under founder Patrick Soon-Shiong, the focus has shifted to proving it can deliver both clinical breakthroughs and consistent revenue growth. With ANKTIVA showing quarter-after-quarter gains and a deep pipeline, 2026 could mark a pivotal year in ImmunityBio's evolution from clinical hopeful to established player in immuno-oncology.