Biotech News

ImmunityBio Announces Resubmission of Supplemental BLA to the FDA for ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC with Papillary Disease Following Agency Review of Additional Data

ImmunityBio (IBRX)ImmunityBio2026-03-09 11:30 ESTFDA / regulatory

Following multiple meetings with the FDA, ImmunityBio submitted additional information requested by the Agency to support its supplemental BLA (sBLA) for papillary disease The FDA reviewed the additional data provided by ImmunityBio in February 2026, and based on the Agency's feedback, the Company

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ImmunityBio

Immune-Based Cancer Therapies ImmunityBio develops therapies that activate innate and adaptive immune responses against cancer. Its platform combines cytokine biology, cell therapy and immunotherapy combinations. ANKTIVA ANKTIVA is an IL-15 superagonist approved with BCG for selected patients with BCG-unresponsive non-muscle-invasive...

Recent company news

IBRXImmunityBio2026-11-04 13:00 EST

ImmunityBio Announces First Patients in Europe Treated with ANKTIVA® Plus BCG for BCG-unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ

IBRXImmunityBio2026-10-21 11:30 EST

ImmunityBio Announces Database Lock for Registrational Trial of Locally Delivered, Chemotherapy-Free ANKTIVA® Plus BCG in BCG-Naïve Non-Muscle Invasive Bladder Cancer

IBRXImmunityBio2026-10-16 15:49 EST

ImmunityBio Reports Phase 3 Data Showing 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors

IBRXImmunityBio2026-10-14 20:18 EST

FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease

IBRXImmunityBio2026-10-08 12:30 EST

ImmunityBio to Participate in the Piper Sandler Virtual Oncology Symposium

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Close: 8.01 USD
Market cap: 7.57B USD
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Sector: Biopharma
Location: United States