---
schema_version: "secwatch.filing_event.v1"
accession: "0001326110-26-000004"
form_type: "8-K"
ticker: "IBRX"
cik: "0001326110"
company_name: "ImmunityBio, Inc."
filed_at: "2026-01-14T23:59:59+00:00"
generated_at: "2026-05-16T10:19:41.262292+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Saudi FDA grants accelerated approval for ImmunityBio's ANKTIVA in NSCLC and NMIBC

## Summary
- SFDA approved ANKTIVA + checkpoint inhibitor for metastatic NSCLC after standard-of-care failure; first worldwide approval for this subcutaneous IL-15 agonist.
- Approval based on QUILT-3.055 and QUILT-2.023 showing lymphocyte recovery and survival association; confirmatory trial ResQ-201A recruiting.
- SFDA also approved ANKTIVA + BCG for BCG-unresponsive NMIBC with CIS, adding to U.S., U.K., and conditional EU approvals.
- ImmunityBio plans regional office in Saudi Arabia and partner Biopharma Cigalah for MENA commercial distribution; NMIBC trial enrollment ahead of schedule, BLA submission by year-end.

## SEC filing metadata
- accession: 0001326110-26-000004
- form_type: 8-K
- ticker: IBRX
- cik: 0001326110
- company_name: ImmunityBio, Inc.
- filed_at: 2026-01-14T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1326110/000132611026000004/0001326110-26-000004-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1326110/000132611026000004/ibrx-20260114.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001326110-26-000004
- JSON: https://secwatch.observer/filing/0001326110-26-000004.json
- Plain text: https://secwatch.observer/filing/0001326110-26-000004.txt

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