ImmunityBio Receives FDA RMAT Designation for ANKTIVA® and CAR-NK for the Reversal of Lymphopenia in Patients Receiving Standard-of-Care Chemotherapy/Radiotherapy and in Treatment of Multi...
ImmunityBio, Inc. (IBRX)
Company Research
Source: Business Wire
Regenerative Medicine Advanced Therapy (RMAT) designation follows clinical data of Absolute Lymphocyte Count (ALC) and significant Overall Survival (OS) correlations in QUILT trials across multiple tumor types, including third line or greater metastatic pancreatic cancer, checkpoint relapsed NSCLC, and supportive data from healthy volunteersThe reversal of lymphopenia by ImmunityBio’s IL-15 superagonist is consistent with the mechanism of action of ANKTIVA demonstrating proliferation and activation of NK cells, CD4+ T cells, CD8+ T cells and memory T cells without upregulation of suppressive T regulatory cells and approved in the ANKTIVA labelCompany intends to submit Biologic License Application (BLA) for the indication of reversal of lymphopenia in patients receiving standard-of-care chemotherapy and/or radiation and for the treatment of locally advanced or metastatic pancreatic cancer, which includes the first-in-class CAR-NK (PD-L1 t-haNK)ImmunityBio to provide data from fully enr
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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