ImmunityBio, Inc. (NASDAQ: IBRX) shares experienced a significant surge of approximately 16% in premarket trading on Tuesday, January 20, 2026, reaching $6.40 at 9:05 AM EST. This upward movement follows positive developments from a recent regulatory meeting with the U.S. Food and Drug Administration.
The biotechnology company announced that the FDA has provided a clear pathway for potentially resubmitting its supplemental Biologics License Application (sBLA) for ANKTIVA. This application aims to expand the approved label of ANKTIVA, its bladder cancer immunotherapy, to include BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.
This latest gain extends a remarkable rally for ImmunityBio shares, which have more than doubled in value over the past week. The stock closed at $5.52 on January 16, marking an increase of nearly 40% from its previous close of $3.95.
FDA Signals Clear Path for ANKTIVA Label Expansion
ImmunityBio recently held a Type B End-of-Phase meeting with the FDA to discuss its planned sBLA for ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-unresponsive NMIBC with papillary tumors. During the meeting, the company presented over five years of follow-up data. This data demonstrated approximately 96% bladder cancer-specific survival at 36 months and greater than 80% bladder preservation at three years, with median outcomes not yet reached.
The FDA recommended that ImmunityBio submit additional information to support a potential resubmission of the sBLA. The application was initially refused in May 2025.
Critically, the additional data required by the FDA does not necessitate the initiation or design of any new clinical trials, which represents a significant positive development for investors. ImmunityBio indicated that it has already compiled the requested information and plans to submit it to the agency within the next 30 days.
This expedited timeline suggests the company could potentially achieve label expansion approval in 2026. This would address a significant unmet medical need for patients who currently have no approved treatment options aside from radical cystectomy, a life-altering surgical procedure that involves the complete removal of the bladder.
IBRX Rallies as Investors React to New Data and Momentum
IBRX shares have experienced extraordinary momentum, with a 137% stock surge following positive clinical results and substantial revenue growth. The stock opened at $4.72 on January 16 and traded in a range of $4.38 to $5.58 during the session. Trading volume was exceptional, with 182.35 million shares exchanged compared to its average volume of 16.06 million.
The company’s market capitalization now stands at approximately $5.44 billion. Analyst price targets range from $6.00 to $24.00, with an average target of $10.80, suggesting further upside potential from current levels.
The proposed label expansion is supported by long-term results from the QUILT-3.032 Phase 2/3 trial, which were recently published in The Journal of Urology. The study enrolled 80 patients with BCG-unresponsive high-grade papillary-only NMIBC and met its primary endpoint with a 12-month disease-free survival rate of 58.2%. More impressively, patients demonstrated a 96.0% disease-specific survival rate at 36 months, with median survival not yet reached, and a progression-free survival of 83.1% at 36 months.
The therapy also showed remarkable bladder-sparing benefits. Cystectomy-free survival was 92.2% at 12 months and 81.8% at 36 months, indicating that over 80% of patients avoided radical surgery through three years of follow-up. ANKTIVA is already approved in the United States, United Kingdom, and Saudi Arabia for NMIBC with carcinoma in situ (CIS) with or without papillary tumors. It has also received conditional approval in the European Union.