Time-Sensitive: Allegations Focus on False Promotional Communications About ANKTIVA
NEW YORK, April 29, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP alerts investors in ImmunityBio, Inc. (NASDAQ: IBRX) of a pending securities class action. Class Period: January 19, 2026 through March 24, 2026. Check if you can recover your investment losses or contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com | (212) 363-7500.
IBRX shares fell $1.98 per share, or 21%, closing at $7.42 on March 24, 2026. The Court has set May 26, 2026 as the deadline to apply for lead plaintiff appointment.
The Alleged Off-Label Promotion Campaign
The lawsuit asserts that ImmunityBio engaged in a coordinated promotional campaign across television advertisements and a nationally broadcast podcast that falsely characterized ANKTIVA as a treatment for "all cancers," as a "Cancer Therapeutic Vaccine," and as a therapy that could prevent cancer in radiation-exposed individuals. ANKTIVA is approved only for a narrow subset of bladder cancer patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ.
As alleged, bladder cancer represents just 4.2% of estimated new cancer cases in 2025, and the approved patient population is an even smaller fraction. The promotional materials allegedly expanded ANKTIVA's positioning far beyond anything supported by clinical data or FDA approval.
Prescription Drug Advertising Violations in Oncology
The action claims that the Company's promotional communications violated multiple provisions of the Federal Food, Drug, and Cosmetic Act and FDA advertising regulations. The complaint identifies these alleged violations:
- TV advertisements and podcast content allegedly misbranded ANKTIVA by suggesting efficacy across all cancer types without supporting clinical evidence
- Promotional materials allegedly depicted subcutaneous injection of the drug, despite ANKTIVA being approved for intravesical use only, with the prescribing information explicitly warning against subcutaneous, intravenous, or intramuscular administration
- The campaign allegedly labeled ANKTIVA as a vaccine for cancer with preventive capabilities, when the drug is, in reality, an IL-15 receptor agonist with no demonstrated preventative effect
- Management allegedly promoted ANKTIVA as a rescue therapy for lung cancer patients who failed checkpoint inhibitors, a use for which the drug has no approval
- The podcast was allegedly not submitted to the FDA at the time of initial dissemination as required by 21 CFR 314.81(b)(3)(i)
What Management Allegedly Knew
The lawsuit asserts that the Company's leadership was aware, or recklessly disregarded, that these promotional claims had no basis in ANKTIVA's approved labeling or clinical trial data. The QUILT-3.032 study, the sole basis for ANKTIVA's approval, was a single-arm trial in 77 patients that evaluated the drug only in combination with BCG. A cohort evaluating ANKTIVA as a single agent was stopped early for futility. The FDA's subsequent Warning Letter, dated March 13, 2026, determined these promotional communications were "false or misleading" and created "a misleading impression that Anktiva, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer."
Speak with an attorney about recovering damages or call (212) 363-7500.
"Investors deserve transparency about material risks that could affect their investments. When a company promotes a drug for uses well beyond its approved indication, the resulting regulatory consequences can cause substantial harm to shareholders who relied on those representations." -- Joseph E. Levi, Esq.
WHY LEVI & KORSINSKY -- Ranked in ISS Securities Class Action Services' Top 50 Report for seven consecutive years, Levi & Korsinsky, LLP is a nationally recognized leader in shareholder rights litigation. With a team of over 70 professionals, the firm has recovered hundreds of millions of dollars for investors.
Frequently Asked Questions About the IBRX Lawsuit
Q: Who is eligible to join the IBRX investor lawsuit? A: Investors who purchased IBRX stock or securities between January 19, 2026 and March 24, 2026 and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses, not on whether you still hold the shares.
Q: How much did IBRX stock drop? A: Shares fell approximately 21%, a decline of $1.98 per share, after the FDA Warning Letter regarding false and misleading promotional communications for ANKTIVA was publicized. Investors who purchased shares during the class period at artificially inflated prices may be entitled to compensation.
Q: What specific misstatements does the IBRX lawsuit allege? A: The complaint alleges ImmunityBio made materially false or misleading statements regarding ANKTIVA's efficacy, approved uses, and route of administration through a podcast and TV advertisements during the class period. When the FDA Warning Letter was publicized, the stock price declined sharply.
Q: What do IBRX investors need to do right now? A: Gather brokerage records including purchase dates, share quantities, and prices paid. Contact Levi & Korsinsky for a free, no-obligation evaluation at jlevi@levikorsinsky.com or (212) 363-7500. No immediate action is required to remain eligible as a class member.
Q: What is a lead plaintiff and why does it matter? A: A lead plaintiff is the investor appointed by the court to represent the entire class. Lead plaintiffs are typically investors with the largest documented losses. Being appointed does not increase individual recovery but gives direct oversight of how the case is run.
Q: What if I already sold my IBRX shares, can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold them. Investors who bought during the class period and sold at a loss may still participate.
Q: What does it cost me to participate? A: Nothing. Securities class actions are handled on a pure contingency basis. No upfront fees, no retainer, no out-of-pocket costs.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171
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