TLDR
- ImmunityBio stock jumped 19.8% in premarket trading after productive FDA meeting about ANKTIVA bladder cancer treatment
- FDA recommended submitting additional information for supplemental application but did not request new clinical trials
- Long-term data shows approximately 96% bladder cancer-specific survival and over 80% bladder preservation at three years
- Company plans to provide requested FDA information within 30 days for label expansion application
- Piper Sandler analyst raised price target to $7.00 from $5.00 with Overweight rating
ImmunityBio stock rose 19.8% in premarket trading Tuesday following news of productive discussions with the FDA. The meeting focused on the company’s supplemental Biologics License Application for ANKTIVA.
ImmunityBio, Inc., IBRX
The immunotherapy company held a Type B End-of-Phase meeting with the FDA. The discussion centered on ANKTIVA’s potential use in treating BCG-unresponsive papillary non-muscle invasive bladder cancer.
The FDA provided specific recommendations during the meeting. The agency asked ImmunityBio to submit additional information to support a resubmission of its application.
The company received welcome news about study requirements. The FDA did not request any new clinical trials for the application.
ImmunityBio plans to move quickly on the FDA’s requests. The company stated it will provide the requested information within 30 days.
The treatment already has FDA approval for certain bladder cancer patients. ANKTIVA received approval in April 2024 for patients with carcinoma in situ with or without papillary tumors.
Strong Clinical Data Supports Treatment
Long-term data published in The Journal of Urology demonstrates the treatment’s effectiveness. The study showed approximately 96% bladder cancer-specific survival at three years.
The data also revealed high bladder preservation rates. Over 80% of patients maintained their bladders at the three-year mark.
The study followed 80 patients with papillary disease. Median outcomes have not yet been reached in this patient population.
The company faced a setback earlier in the process. In May 2025, the FDA issued a Refusal to File letter regarding the supplemental application for papillary tumors.
International Approvals Expand Reach
ANKTIVA has gained regulatory approvals beyond the United States. The treatment secured approvals in the United Kingdom and Saudi Arabia.
The European Union granted conditional approval for the therapy. This expands the potential patient population across multiple markets.
Richard Adcock, President and CEO of ImmunityBio, expressed appreciation for the regulatory process. He stated the company remains committed to delivering the therapy to patients without approved alternatives.
Wall Street analysts responded positively to the news. Piper Sandler analyst Edward Tenthoff raised his price target on ImmunityBio to $7.00 from $5.00.
The analyst maintained an Overweight rating on the stock. This reflects confidence in the company’s regulatory pathway forward.
The stock’s movement follows a strong previous week. Shares had more than doubled in value before Tuesday’s premarket gains.
The company plans to submit additional data within the 30-day timeline without conducting further clinical studies.
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