ImmunityBio Revenue Surge Boosts Pipeline Momentum
ImmunityBio revenue surge from $113 million in Anktiva sales and QUILT updates strengthens outlook and shifts positioning toward registrational upside
KEY TAKEAWAYS
- Preliminary 2025 net product revenue was $113 million, up 700% year over year, mainly from Anktiva.
- QUILT-106 updates showed sustained complete responses up to 15 months and no serious adverse events.
- QUILT-2.005 enrollment exceeded 85% with full enrollment expected by Q2 2026 to support a BLA.
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ImmunityBio (IBRX) reported a revenue surge driven by expanding Anktiva sales and updated QUILT trial data, strengthening its commercial outlook and accelerating registrational timelines, the company said in press releases.
Commercial Momentum Driven by Anktiva
Preliminary net product revenue for 2025 reached $113 million, a 700% increase from $14.15 million the prior year. Fourth-quarter revenue was $38.3 million, up 431% year over year and 20% sequentially. The company attributed this growth mainly to Anktiva (nogapendekin alfa inbakicept) sales in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). It said the expanded commercial base, along with ongoing geographic and indication activity, supports near-term revenue durability.
Clinical Advances Signal Registrational Momentum
On January 16, 2026, the company reported updated QUILT-106 data showing that an off-the-shelf allogeneic CD19 CAR-NK therapy (t-haNK) combined with rituximab achieved disease control in all four patients with Waldenström lymphoma. Two evaluable patients have ongoing complete responses at about seven and 15 months after eight doses (four cycles). The regimen was administered outpatient without chemotherapy or lymphodepletion and caused no serious adverse events. Follow-up continues, and a follow-on study will combine CD19 CAR-NK with Anktiva plus rituximab. The company said, "Updated follow-up demonstrates sustained complete responses with durations now extending to 15 months and ongoing."
The company also said enrollment in QUILT-2.005, a randomized registrational trial of Anktiva plus BCG in BCG-naïve NMIBC, has exceeded 85% of the planned population, surpassing internal expectations. It anticipates full enrollment by the second quarter of 2026 and intends the trial to support a biologics license application submission.
Saudi Approval and Promotional Risk
On January 14, 2026, ImmunityBio said the Saudi Food and Drug Authority granted accelerated approval for Anktiva combined with immune checkpoint inhibitors in metastatic non-small-cell lung cancer (NSCLC) after progression on standard therapy. The approval cited an association between increases in absolute lymphocyte counts and survival observed in QUILT-3.055 and QUILT-2.023 trials. The company described this as the first worldwide approval of a subcutaneous IL-15 agonist in this indication.
The company noted prior regulatory milestones for Anktiva, including U.S. FDA approval in 2024 for BCG-unresponsive carcinoma in situ with BCG and approvals or conditional authorizations in the U.K. and EU. It has also acknowledged an FDA warning letter concerning promotional material related to efficacy statistics.
Combined commercial gains from Anktiva sales and recent clinical and regulatory developments support a stronger near-term commercial runway and advance registrational momentum into 2026.
