ImmunityBio's Sequential ANKTIVA Revenue Streak Ends

The Tip Desk · November 9, 2026 · 4 min read

Third-quarter net product revenue was $48.7 million, up 53% from a year earlier, as the FDA expanded the ANKTIVA label and the company met a BCG-naïve trial endpoint.

ImmunityBio, Inc. (IBRX), a commercial-stage immunotherapy company, reported third-quarter net product revenue of $48.7 million, up 53% from a year earlier, as the FDA expanded the ANKTIVA label and the company met a BCG-naïve trial endpoint.

The sequential run that had defined the commercial launch stalled. Revenue fell from a record $50.7 million in the second quarter, reversing the prior quarter’s 15% sequential increase and ending the streak of sequential growth the company had highlighted since ANKTIVA’s launch. Year-over-year growth slowed to 53% from 92% in the second quarter. The company attributed the year-over-year increase to continued adoption among U.S. urologists and strong market access.

For the first nine months of 2026, net product revenue totaled $143.6 million, up 92% from the first nine months of 2025, building on full-year 2025 net product revenue of $113.0 million.

On October 14, 2026, the FDA approved a supplemental Biologics License Application expanding ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) to adult patients with BCG-unresponsive non-muscle invasive bladder cancer, including high-grade papillary-only tumors. The company said the expanded indication had already been authorized by the Emirates Drug Establishment of the United Arab Emirates and that it would pursue global filings for the expanded label.

In November 2026, ImmunityBio reported that the primary endpoint for Cohort A was met in the randomized QUILT-2.005 trial of ANKTIVA plus BCG versus BCG alone in BCG-naïve NMIBC. The company said it remains on track to submit an sBLA for that population in the fourth quarter of 2026. President and CEO Richard Adcock said the label expansion is an opportunity to broaden access and that QUILT-2.005 offers another potential avenue for expanding the eligible patient population, subject to positive clinical and regulatory approval.

Global access widened. ANKTIVA is now approved or authorized in six regulatory jurisdictions and 35 countries, up from five jurisdictions and 34 countries as of the second-quarter release, after approval in Israel in collaboration with Rafa Laboratories Ltd. and the first commercial doses administered in Europe in early fourth quarter.

On October 16, 2026, The Journal of Urology published long-term outcomes from the Phase 2/3 QUILT-3.032 trial in 100 patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors. Among responders, cystectomy avoidance was 84% at 36 months. Median duration of complete response was 26.6 months, with some responses extending beyond 53 months. Founder, Executive Chairman and Global Chief Scientific and Medical Officer Patrick Soon-Shiong said the FDA approval and the published data reinforce the clinical potential of the chemotherapy-free approach.

Research and development expense rose to $71.5 million in the three months ended September 30, 2026, from $51.2 million a year earlier, mainly from higher clinical trial and personnel costs, partially offset by lower manufacturing expenses. Selling, general and administrative expense rose to $54.0 million from $36.3 million a year earlier, mainly from higher professional services, personnel, and commercial-related costs.

Other expense, net widened to $106.6 million from $11.7 million a year earlier, primarily from non-cash fair-value changes on a related-party convertible note, warrant liabilities, and other derivative liabilities tied to a higher common stock price, plus higher interest on the revenue interest liability after additional funding received in the first quarter of 2026. Those changes were partially offset by higher interest and investment income and lower interest expense after a partial loan conversion.

Net loss attributable to common stockholders widened to $184.6 million from $67.3 million a year earlier, or $0.18 a share on a diluted basis, versus $0.07 a share. The company said the increase was driven mainly by those fair-value changes, higher revenue-interest interest expense, and higher R&D and SG&A, partially offset by higher product revenue. Adjusted net loss attributable to common stockholders increased $25.5 million to $97.9 million from $72.4 million a year earlier.

Cash and cash equivalents plus marketable securities declined to $334.3 million as of September 30, 2026, from $357.4 million as of June 30, 2026. Cash used in operating activities was $75.3 million in the quarter.

The company said it continued to advance clinical programs in metastatic non-small cell lung cancer, glioblastoma, and hematologic malignancies during the quarter.