# ImmunityBio

Type: Company (IBRX)

Source: Biotech Intelligence Brief — https://getbiobrief.com/entity/immunitybio
Canonical HTML page: https://getbiobrief.com/entity/immunitybio

## Timeline

- **2026-03-24**: Regulatory Warning — FDA flags misleading claims made by Patrick Soon-Shiong regarding off-label uses of Anktiva.
- **2024-04-22**: FDA Approval — Anktiva is approved for BCG-unresponsive NMIBC in combination with BCG.
- **2023-05-01**: Initial Rejection — FDA issues a Complete Response Letter (CRL) for Anktiva due to manufacturing deficiencies.

## Recent coverage (2 stories)

### FDA Flags Misleading Cancer Drug Claims by ImmunityBio’s Patrick Soon-Shiong
2026-03-24 20:20:13 · Sentiment: Negative · Impact: 7/10 · Sources: 2

The FDA has issued a formal warning to Dr. Patrick Soon-Shiong, the billionaire founder of ImmunityBio, regarding misleading statements made about the company’s bladder cancer therapy, Anktiva. The regulator flagged claims made during a podcast that suggested the drug could treat a broader range of cancers than its current approval allows.
Full story: https://getbiobrief.com/story/fda-warning-immunitybio-patrick-soon-shiong-anktiva

### ImmunityBio Shares Surge as EU Approves ANKTIVA for Bladder Cancer
2026-02-18 23:26:51 · Sentiment: Positive · Impact: 7/10 · Sources: 3

ImmunityBio (IBRX) shares rallied following the European Commission's marketing authorization of ANKTIVA for BCG-unresponsive non-muscle invasive bladder cancer. This milestone marks the first international expansion for the IL-15 superagonist, significantly broadening its global commercial reach.
Full story: https://getbiobrief.com/story/immunitybio-anktiva-eu-approval-bladder-cancer

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