ImmunityBio Announces FDA Submissions of Supplemental BLA for NMIBC Papillary Disease and for Expanded Access of ANKTIVA® to Treat Lymphopenia
ImmunityBio, Inc. (IBRX)
Company Research
Source: Business Wire
Company to Provide Regulatory, Sales, and Platform Updates at Investor Day including:In Q1, the company submitted a supplemental Biologics License Application (sBLA) for use of ANKTIVA® plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease.In Q2, the company submitted to the U.S. Food and Drug Administration (FDA) an Expanded Access Protocol (EAP) for ANKTIVA for the treatment of lymphopenia as a BioShield against the adverse effects of chemotherapy, radiation and checkpoint inhibitors, following authorization of a Regenerative Medicine Advanced Therapy (RMAT) designation for this indication in Q1.With a permanent J-code (J9028) awarded in January 2025, ImmunityBio’s Q1 2025 ANKTIVA unit sales volume grew 150% over unit sales volume in Q4 2024.For the three-month period ended March 31, 2025, ImmunityBio achieved estimated net product revenue of approximately $16.5 million, surpassing net product reve
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News
- ImmunityBio: Anktiva Revenue Will Ramp, But Competitive Risks Remain [Seeking Alpha]Seeking Alpha
- ImmunityBio (NASDAQ:IBRX) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- ANKTIVA® with BCG Demonstrates 96% Survival from Bladder Cancer at Three Years with Median Survival Not Yet Reached in BCG-Unresponsive High-Grade Papillary-Only Non-Muscle Invasive Bladder CancerBusiness Wire
- Should EMA's Conditional Nod for ANKTIVA in High-Risk Bladder Cancer Require Action From ImmunityBio (IBRX) Investors? [Yahoo! Finance]Yahoo! Finance
- ImmunityBio (IBRX) Climbs 7.76% on Europe Expansion [Yahoo! Finance]Yahoo! Finance
IBRX
Earnings
- 5/12/25 - Miss
IBRX
Sec Filings
- 12/16/25 - Form 4
- 12/16/25 - Form 3
- 12/15/25 - Form 8-K
- IBRX's page on the SEC website