TLDR
- ImmunityBio stock jumped 19.8% premarket Tuesday following constructive FDA discussions on ANKTIVA
- FDA guidance allows data submission without requiring new clinical trials for label expansion
- Study results demonstrate 96% survival rate and 80% bladder preservation at three years
- Company targeting 30-day submission timeline for additional information requested by regulators
- Price target increased to $7.00 as analysts respond to regulatory progress
ImmunityBio shares rose 19.8% in premarket trading Tuesday after announcing positive regulatory developments. The company held a Type B End-of-Phase meeting with the FDA regarding ANKTIVA.
The discussion centered on the supplemental Biologics License Application for bladder cancer treatment. Specifically, the application targets BCG-unresponsive non-muscle invasive bladder cancer patients with papillary tumors.
The FDA provided clear direction for moving forward. Regulators recommended submitting additional data to support the application resubmission.
The company received favorable guidance on study requirements. No new clinical trials will be necessary for the supplemental application.
ImmunityBio established a rapid response timeline. The biotech plans to deliver the requested information within 30 days.
The therapy currently holds approval for certain patient populations. ANKTIVA received FDA authorization in April 2024 for carcinoma in situ patients with or without papillary tumors.
Published Data Supports Treatment Potential
The Journal of Urology published compelling long-term results. The study followed 80 patients with papillary disease treated with ANKTIVA.
Three-year data showed approximately 96% bladder cancer-specific survival. More than 80% of patients maintained bladder preservation during this period.
Researchers have not yet reached median outcomes. This indicates the treatment benefits may continue beyond the current timeframe.
The company previously encountered regulatory challenges. The FDA issued a Refusal to File letter in May 2025 for the papillary tumor indication.
Tuesday’s meeting addressed the path forward from that setback. The FDA’s guidance provides a clear roadmap for resubmission.
Market Expansion and Analyst Response
ANKTIVA has gained traction in international markets. Approvals have been secured in the United Kingdom and Saudi Arabia.
The European Union granted conditional approval for the treatment. This expands access for bladder cancer patients across multiple continents.
CEO Richard Adcock highlighted the collaborative regulatory approach. He stressed the company’s commitment to serving patients who lack approved alternatives after standard treatment fails.
Financial analysts updated their outlook on the stock. Piper Sandler’s Edward Tenthoff raised his price target to $7.00 from $5.00.
The Overweight rating remained in place. The analyst’s confidence reflects the clearer regulatory pathway.
Recent Trading Activity
The Tuesday gains build on recent momentum. ImmunityBio stock more than doubled in value during the previous week.
The premarket surge extended those gains. Investor enthusiasm centers on the regulatory progress for label expansion.
The company emphasized it will not conduct additional clinical studies. All requested information can be compiled from existing data sources.
ImmunityBio maintains its 30-day submission target for providing FDA-requested information to support the supplemental Biologics License Application resubmission.
