The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for ImmunityBio’s ANKTIVA® (nogapendekin alfa inbakicept) on December 11 2025, and the agency announced the recommendation on December 12 2025. The recommendation grants a conditional marketing authorization for ANKTIVA in combination with Bacillus Calmette‑Guérin (BCG) to treat BCG‑unresponsive non‑muscle invasive bladder cancer (NMIBC) carcinoma in situ.
The authorization is based on a single‑arm study of 100 adults that reported a 71 % complete response rate, with durable responses averaging 27 months. The conditional pathway allows patients to access the therapy while ImmunityBio continues to collect long‑term safety and efficacy data, a requirement that the EMA will monitor closely.
The approval expands ImmunityBio’s addressable patient population beyond the United States and the United Kingdom, where ANKTIVA was already approved. CEO Richard Adcock said the company is “looking forward to finalizing plans to bring our innovative treatment to qualified EU patients” and is assessing its launch approach in light of the U.S. Most‑Favored‑Nation Prescription Drug Pricing policy. The company also highlighted its development of a recombinant BCG candidate to mitigate ongoing BCG shortages, which could strengthen ANKTIVA’s value proposition in the EU market.
Financially, ImmunityBio’s Q3 2025 product revenue reached $31.8 million, a 434 % year‑over‑year increase, and year‑to‑date sales hit $74.7 million, up 467 % from the prior year. The company ended the quarter with $257.8 million in cash, cash equivalents, and marketable securities, underscoring the financial resources available to support the EU launch and post‑marketing commitments.
Investors reacted positively to the regulatory milestone; the company’s stock rose 3.9 % on the day of the announcement. Analysts noted that the EMA’s conditional approval is a significant commercial opportunity, as it is the first IL‑15 superagonist to receive such a recommendation in Europe for this indication.
The competitive landscape in the EU remains limited for BCG‑unresponsive NMIBC, with radical cystectomy as the primary alternative. ANKTIVA’s mechanism—enhancing NK and T‑cell activity—offers a non‑surgical option, and the company’s ongoing work on a recombinant BCG product positions it to address supply constraints that could otherwise limit combination therapy uptake.
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