ImmunityBio to Submit FDA Data for Anktiva Bladder Cancer sBLA in 30 Days

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ImmunityBio will supply additional data to the FDA within 30 days following a Type B end-of-phase meeting on its supplemental biologics license application for Anktiva in papillary non-muscle invasive bladder cancer. The meeting outlined requirements to support label expansion for Anktiva’s immune-activating therapy targeting high-risk NMIBC patients.

1. ImmunityBio Shares Surge as Short Squeeze Intensifies

ImmunityBio’s stock climbed roughly 7% in a single session, extending a three-week rally that has seen the share price triple year-to-date. Trading volume reached approximately 96 million shares, nearly five times its three-month average of 19 million, as short-sellers scrambled to cover positions. With roughly 35% of the public float sold short before the rally began, bearish investors now face an estimated $500 million paper loss. The company’s market capitalization stands at $6.4 billion and its latest quarterly gross margin was 80.4%. These dynamics underscore growing investor confidence in ImmunityBio’s pipeline and highlight the risks associated with heavily shorted, high-volatility stocks.

2. FDA Talks Pave Way for Anktiva Expansion

ImmunityBio announced that it has agreed to submit additional data to the U.S. Food and Drug Administration within 30 days following a Type B end-of-phase meeting regarding its supplemental biologics license application for Anktiva in papillary non-muscle invasive bladder cancer. The discussions focused on optimized dosing regimens and biomarker analyses to support broader label claims beyond the current indication. If approved, the expanded label could open a larger patient population and drive incremental revenue, building on Anktiva’s demonstrated efficacy and safety profile in prior clinical studies.

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