ImmunityBio reports progress on bladder cancer filing, shares trade quietly on NASDAQ
25.06.2026 - 19:24:30 | ad-hoc-news.de
By Daniel Hoffmann, Chart & Technicals desk. Reviewed prior to publication on 2026-06-25, 19:24.
ImmunityBio Inc (US45258J1025) remains in focus for biotech investors after it received a complete response letter from the U.S. Food and Drug Administration (FDA) in 2024 for its lead bladder cancer therapy N-803 and has been working toward a resubmission of its Biologics License Application, as company filings show. The stock trades on the NASDAQ in New York, placing it among U.S.-listed mid-cap biotech names.
Regulatory path for N-803
ImmunityBio disclosed in May 2024 that the FDA had issued a complete response letter for the Biologics License Application for N-803 in combination with Bacillus Calmette-Guerin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer, citing manufacturing and inspection issues rather than new clinical data concerns, according to the company's communication. ImmunityBio's investor relations news archive details the CRL and planned resubmission This regulatory outcome keeps the pivotal QUILT 3.032 trial at the center of the company's value case, as the study underpins the efficacy data package presented to the agency.
In its updates, ImmunityBio has emphasized that it intends to address the FDA's observations by working with a contract manufacturing organization and enhancing quality controls, which is designed to resolve the issues highlighted in the complete response letter. Management has also indicated that it continues to discuss the regulatory path forward with the FDA to achieve a potential approval in the U.S. market for this indication.
Analyst views and biotech peer context
Equity research coverage of ImmunityBio on financial data platforms shows a speculative profile, with analysts generally highlighting both the sizable commercial opportunity in non-muscle invasive bladder cancer and the elevated regulatory and financing risks typical for clinical-stage oncology companies. MarketScreener's consensus overview summarizes current analyst ratings and target prices for the stock The company is often compared with other immuno-oncology developers such as Iovance Biotherapeutics and Agenus that also rely on a small number of advanced-stage assets.
Recent sector commentary from U.S. market outlets notes that biotech shares in general have traded with elevated volatility in 2026, as investors react to trial readouts, FDA decisions and capital-raising plans across the group. A Reuters overview of biotech sector performance in June 2026 highlights how regulatory milestones drive sharp share-price moves in mid-cap names In that environment, ImmunityBio's pending resubmission of its bladder cancer filing is seen as a key potential catalyst once a clear timeline emerges.
All news and analysis on the ImmunityBio shares
Follow further regulatory, clinical and financing developments for ImmunityBio and how they influence the company's NASDAQ-listed stock.
How ImmunityBio aims to generate revenue
ImmunityBio's business model centers on developing immunotherapies that harness the patient's own immune system to fight cancer and infectious diseases, with N-803 (also known as Anktiva) as the most advanced late-stage asset targeting bladder cancer and other indications. The strategy is to secure regulatory approvals, then monetize via direct commercialization in the U.S. and partnerships abroad.
Where the stock trades today
ImmunityBio shares last changed hands at 7.85 U.S. dollars on the NASDAQ, based on the latest available closing price data as of 2026-06-24.
ImmunityBio at a glance
- Company: ImmunityBio Inc.
- ISIN: US45258J1025
- WKN: A2P1G1
- Ticker: IBRX
- Trading venue: NASDAQ
- Price (as of 2026-06-24, 21:59): 7.85 USD
- Market cap: 3.4 billion USD (as of 2026-06-24)
- Sector / industry: Biotechnology / Immuno-oncology
- Index membership: Not a member of major headline indices such as S&P 500 or NASDAQ-100
- Next earnings date: not officially scheduled
This article was produced with AI assistance and editorially reviewed. Price and company figures without guarantee; prices and dates may change at short notice. No investment advice, no buy or sell recommendation. Stock-market transactions carry risks up to and including total loss.
