IBRX Stock Declines — ImmunityBio Resubmits Anktiva Application To FDA With Additional Data

• Following discussions with the FDA beginning in January 2026, ImmunityBio resubmitted its supplemental BLA for papillary-only NMIBC after providing additional data requested by the agency, including updated efficacy results.
• The filing includes long-term follow-up data and study results for Anktiva plus Bacillus Calmette-Guérin in patients with bladder cancer and papillary tumors, published in The Journal of Urology.
• ImmunityBio plans to present clinical data supporting the Saudi Food and Drug Authority approval of the chemotherapy-free regimen of Anktiva plus checkpoint inhibitors.

ImmunityBio Inc. (IBRX) on Monday announced that it has resubmitted the supplemental biologics license application (BLA) to the U.S. Food and Drug Administration for Anktiva.

ImmunityBio stated that the application includes additional information requested by the FDA to support its supplemental BLA for papillary disease.

ImmunityBio shares were down more than 1% in Monday’s opening trade. Retail sentiment on Stocktwits around the company trended in the ‘bearish’ territory at the time of writing.

Filing Includes Long-Term Follow-Up Data

Following discussions with the FDA beginning in January 2026, ImmunityBio resubmitted its supplemental BLA for papillary-only NMIBC after providing additional data requested by the agency, including updated efficacy results.

The filing includes long-term follow-up data, and safety and efficacy results for Anktiva plus BCG in BCG-unresponsive NMIBC with papillary tumors have been published in The Journal of Urology.

"As far back as 2007, IL-15 was identified by leading scientific and medical organizations, including the NCI, NIH, FDA, AACR, and ASH, as the number one-ranked immunotherapy molecule with the potential to cure cancer," said Dr. Patrick Soon-Shiong, ImmunityBio’s founder and Executive Chairman.

ImmunityBio Plans To Present Data Supporting Saudi Approval

ImmunityBio plans to present clinical data supporting the Saudi Food and Drug Authority (SFDA) approval of the chemotherapy-free regimen of Anktiva plus checkpoint inhibitors, which showed nearly twice the median overall survival compared with historical outcomes with docetaxel chemotherapy.

The company said it will also continue discussions with the FDA and other global regulators on potential treatment options for patients with second-line and later metastatic non-small cell lung cancer (NSCLC) who have exhausted current standards of care, including checkpoint inhibitors.

ImmunityBio’s Partnership To Expand Anktiva Access

In March, the company partnered with Accord Healthcare to expand access to Anktiva across 30 countries. It also established an Irish subsidiary in Dublin to support its distribution and commercialization strategy across Europe.

Under the agreement, Accord will deploy more than 100 sales, medical, and marketing professionals to support the adoption of Anktiva across the United Kingdom, the European Union, Norway, Iceland, and Liechtenstein.

Soon-Shiong said the company aims to broaden access to Anktiva by completing a randomized trial in patients with BCG-naïve disease.

This includes individuals with non-muscle invasive bladder cancer (NMIBC) who have never received Bacillus Calmette-Guérin (BCG) immunotherapy or whose cancer recurs more than 24 months after prior BCG treatment.

IBRX stock is up 332% year-to-date and 185% over the past 12 months.

Also See: RLMD Stock Soars Pre-Market: Phase 2 Bladder Cancer Trial Data Impresses Investors

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