TLDR
- ImmunityBio shares surged 19.8% in premarket trading after positive FDA meeting on ANKTIVA bladder cancer therapy
- FDA asked for additional data submission but no new clinical trials required for supplemental application
- Three-year study data shows 96% cancer-specific survival and 80% bladder preservation in patients
- Company will submit requested information within 30 days to support label expansion resubmission
- Analyst upgraded price target to $7.00 from $5.00 following the regulatory update
ImmunityBio stock climbed 19.8% in premarket trading Tuesday after the company reported constructive discussions with the FDA. The meeting addressed the supplemental Biologics License Application for ANKTIVA in bladder cancer treatment.
The clinical-stage immunotherapy company received encouraging feedback from regulators. The FDA recommended submitting additional information to support the application resubmission.
Most importantly, the agency did not require new clinical trials. This saves the company time and resources in the approval process.
ImmunityBio outlined a clear timeline for next steps. The company plans to provide the requested information within 30 days.
The meeting focused on ANKTIVA combined with Bacillus Calmette-Guérin for BCG-unresponsive non-muscle invasive bladder cancer with papillary tumors. The therapy already has approval for patients with carcinoma in situ.
Clinical Data Demonstrates Treatment Effectiveness
Published data in The Journal of Urology supports the treatment’s potential. The study tracked 80 patients with papillary disease over three years.
Results showed approximately 96% bladder cancer-specific survival. The preservation rate exceeded 80% for patients maintaining their bladders.
The median outcomes have not been reached yet. This suggests the benefits may extend beyond the current three-year data.
ANKTIVA received initial FDA approval in April 2024. The treatment is available for CIS patients with or without papillary tumors who are unresponsive to BCG.
The company faced a regulatory hurdle in May 2025. The FDA issued a Refusal to File letter for the supplemental application targeting papillary tumors specifically.
Global Approvals and Market Response
ANKTIVA has secured approvals in multiple international markets. The United Kingdom and Saudi Arabia have granted authorization for the therapy.
The European Union provided conditional approval. This extends the treatment’s reach to patients across various regions.
Richard Adcock, President and CEO of ImmunityBio, acknowledged the collaborative regulatory process. He emphasized the company’s dedication to providing options for patients without approved alternatives when standard care fails.
Wall Street reacted positively to the regulatory update. Piper Sandler analyst Edward Tenthoff increased his price target to $7.00 from $5.00.
The analyst kept an Overweight rating on the stock. This signals confidence in the regulatory pathway ahead.
The Tuesday premarket gains followed a strong prior week. ImmunityBio shares had more than doubled in value before the latest jump.
The company will not need to conduct additional clinical studies. ImmunityBio stated it will provide the FDA-requested data within the 30-day timeframe to support the supplemental application resubmission.
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