ImmunityBio's Anktiva Advances Toward EU Approval for Bladder Cancer

In December 2025, the European Medicines Agency recommended a conditional marketing authorization for Anktiva in combination with Bacillus Calmette-Guérin (BCG) for treating adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ. A conditional marketing authorization is an EU regulatory mechanism designed to facilitate early access to medicines that address an unmet medical need.

The EMA's opinion will now be forwarded to the European Commission for final approval of EU-wide marketing authorization. Investors are anticipating a decision as early as next Monday.

Anktiva in combination with BCG is already approved in multiple regions for BCG-unresponsive NMIBC CIS, including in the U.S.

Earlier this year, the company said it is eyeing the resubmission of its application to the FDA seeking approval for Anktiva in BCG-unresponsive NMIBC with papillary tumors. The company had a meeting with the agency and it recommended that the company submit additional information for its evaluation within the next 30 days. It filed an application last year but the FDA issued a refuse to file letter, indicating that the application is incomplete.

ImmunityBio (IBRX) shares have gained 79% over the past 12 months. Retail sentiment on Stocktwits remains bearish, though investors are showing strong interest in the potential approval of Anktiva. Some investors have increased their holdings in IBRX after seeing a price dip, believing that Anktiva's approval will lead to significant stock price appreciation.