---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-112057"
form_type: "8-K"
ticker: "IBRX"
cik: "0001326110"
company_name: "ImmunityBio, Inc."
filed_at: "2025-05-05T23:59:59+00:00"
generated_at: "2026-05-22T16:48:50.591956+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# ImmunityBio receives FDA refusal to file for ANKTIVA sBLA in NMIBC papillary indication

## Summary
- FDA issued Refusal to File (RTF) letter on May 2, 2025 for sBLA of ANKTIVA+BCG in BCG-unresponsive papillary NMIBC.
- Company cites unanimous January 2025 FDA leadership guidance encouraging sBLA submission; RTF called inconsistent.
- Existing approval for CIS +/- papillary (Cohort A) is unaffected; RTF pertains to papillary without CIS (Cohort B).
- Data highlighted: 96% disease-specific survival at 36 months and >82% bladder-sparing rate in the papillary cohort.
- Company requests urgent Type A meeting with FDA; former FDA Principal Deputy Commissioner Dr. Sherman supports appeal.

## SEC filing metadata
- accession: 0001193125-25-112057
- form_type: 8-K
- ticker: IBRX
- cik: 0001326110
- company_name: ImmunityBio, Inc.
- filed_at: 2025-05-05T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1326110/000119312525112057/0001193125-25-112057-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1326110/000119312525112057/d949868d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-112057
- JSON: https://secwatch.observer/filing/0001193125-25-112057.json
- Plain text: https://secwatch.observer/filing/0001193125-25-112057.txt

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