ImmunityBio (IBRX) Resubmits sBLA to FDA for ANKTIVA in Papillary Bladder Cancer

ImmunityBio Inc. (NASDAQ:IBRX) is one of the most buzzing stocks to buy with the highest upside potential. On March 9, ImmunityBio announced the resubmission of its sBLA to the FDA for ANKTIVA in combination with Bacillus Calmette-Guérin/BCG. This filing specifically targets patients with BCG-unresponsive non-muscle invasive bladder cancer/NMIBC who present with papillary disease. The resubmission follows an initial review in early 2026, during which the FDA requested additional long-term efficacy and follow-up data to support the treatment’s potential in this specific patient population.

The sBLA is supported by results from the QUILT 3.032 Phase 2/3 trial, which showed durable outcomes for patients with high-grade papillary-only disease. Data published in The Journal of Urology showed a 12-month disease-free survival rate of 58.2% and a bladder preservation rate of 81.8% at 36 months. These findings highlight ANKTIVA’s role as an IL-15 superagonist that activates natural killer and killer T cells to prevent progression to muscle-invasive disease without the need for chemotherapy.

ImmunityBio (IBRX) Resubmits sBLA to FDA for ANKTIVA in Papillary Bladder Cancer

Beyond this NMIBC indication, ImmunityBio is expanding its global regulatory reach, noting that the Saudi Food and Drug Authority recently approved ANKTIVA for certain metastatic non-small cell lung cancers. ImmunityBio Inc. (NASDAQ:IBRX) remains in discussions with the FDA and other international agencies regarding the use of its immunotherapy platform for various advanced cancers. Currently, the FDA has acknowledged receipt of the papillary NMIBC resubmission as it continues to evaluate the updated clinical data.

ImmunityBio Inc. (NASDAQ:IBRX) is a biotechnology company that innovates, develops, and commercializes next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases.

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