---
schema_version: "secwatch.filing_event.v1"
accession: "0001326110-24-000040"
form_type: "8-K"
ticker: "IBRX"
cik: "0001326110"
company_name: "ImmunityBio, Inc."
filed_at: "2024-04-23T23:59:59+00:00"
generated_at: "2026-06-03T11:33:32.641236+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# ImmunityBio gets FDA approval for ANKTIVA in BCG-unresponsive NMIBC; CR rate 62%, DOR >47 months

## Summary
- FDA approved ANKTIVA (N-803) plus BCG for BCG-unresponsive NMIBC with CIS on April 22, 2024.
- Complete response rate of 62% in evaluable patients; duration of complete response >47 months and ongoing.
- 58% of patients had DOR ≥12 months, 40% had DOR ≥24 months; median DOR not yet reached.
- ANKTIVA expected to be available in U.S. by mid-May 2024; conference call April 26 at 11am EDT.
- Company plans to seek approval to increase shares under 2015 Equity Incentive Plan by up to 19.9M shares.

## SEC filing metadata
- accession: 0001326110-24-000040
- form_type: 8-K
- ticker: IBRX
- cik: 0001326110
- company_name: ImmunityBio, Inc.
- filed_at: 2024-04-23T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1326110/000132611024000040/0001326110-24-000040-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1326110/000132611024000040/ibrx-20240422.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001326110-24-000040
- JSON: https://secwatch.observer/filing/0001326110-24-000040.json
- Plain text: https://secwatch.observer/filing/0001326110-24-000040.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.