ImmunityBio to Submit Anktiva Data to FDA within 30 Days after Type B Meeting

IBRXIBRX

ImmunityBio will submit additional data to the FDA within 30 days after a Type B end-of-phase meeting for its supplemental BLA of Anktiva in papillary non-muscle invasive bladder cancer. Approval of this expanded indication could significantly increase Anktiva’s addressable market in non-muscle invasive bladder cancer, boosting ImmunityBio’s long-term revenue potential.

1. IBRX Stock Surges as Volume Spikes

ImmunityBio shares climbed 6.79% on January 21, closing at $6.92 after adding $0.44 to the previous session. Trading volume reached 96 million shares, nearly 500% above its 19 million–share average, as investors piled into the biotech specialist’s stock. The company’s market capitalization now stands at $6.4 billion, with a day’s range between $5.71 and $7.10. Over the past three weeks, IBRX’s share price has tripled, pushing it toward its 52-week high of $7.98 and marking a stark reversal from its post-IPO decline of roughly 80% since 2015.

2. Short Sellers Face Hefty Paper Losses

Data compiled by Bloomberg indicates that 35% of ImmunityBio’s public float was held short entering 2026. As the stock rallied, short positions amassed nearly $500 million in unrealized losses, prompting many aggressive bearish traders to reassess their strategies. Trading desk sources report that several hedge funds have begun covering, contributing to upward price momentum despite the absence of new company announcements. Executive chairman Patrick Soon-Shiong publicly questioned the rationale behind betting against a company focused on cancer and infectious-disease immunotherapies.

3. FDA Meeting Charts Expansion Path for Anktiva

On Tuesday, ImmunityBio confirmed that it met with the U.S. Food and Drug Administration for a Type B end-of-phase conference on its supplemental Biologics License Application for Anktiva in papillary non-muscle invasive bladder cancer. The company said it will submit additional clinical and manufacturing data within 30 days, aiming to secure an expanded indication for its IL-15 cytokine fusion therapy. Analysts note that approval could significantly broaden Anktiva’s patient base beyond the current high-risk NMIBC cohort, bolstering long-term revenue projections.

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