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ImmunityBio Shares Surge on FDA Meeting Success
20 Jan
Summary
- FDA meeting yielded productive discussions on ANKTIVA for bladder cancer.
- No new clinical trials required for the supplemental application.
- Piper Sandler raises ImmunityBio price target to $7.00.
ImmunityBio, Inc. (IBRX) experienced a significant premarket stock increase of 19.8% on Tuesday, driven by news of successful discussions with the U.S. Food and Drug Administration (FDA). The meeting focused on the supplemental Biologics License Application for ANKTIVA, a treatment for BCG-unresponsive papillary non-muscle invasive bladder cancer.
The FDA offered specific recommendations during the Type B End-of-Phase meeting, guiding ImmunityBio on resubmitting its application. A key positive outcome was the FDA not requesting any new clinical trials, a move that simplifies and accelerates the regulatory process for the immunotherapy drug.
ImmunityBio intends to promptly address the FDA's requests, aiming to submit the required additional information within 30 days. ANKTIVA is already approved for certain bladder cancer patients, having received FDA approval in April 2024 for carcinoma in situ. Long-term data published in The Journal of Urology indicated approximately 96% bladder cancer-specific survival at three years and over 80% bladder preservation.
Despite an earlier Refusal to File letter in May 2025 for the supplemental application, ANKTIVA has also secured regulatory approvals in the United Kingdom and Saudi Arabia, with conditional approval granted by the European Union. In response to the recent developments, Piper Sandler analyst Edward Tenthoff raised his price target for ImmunityBio stock to $7.00 from $5.00, maintaining an Overweight rating.
