IBRX Lawsuit Alleges Company Allegedly Violated Drug Promotion Laws - ImmunityBio Investors Face Losses Following Company Allegedly Violated Drug Promotion Laws: SueWallSt

Alert: Claims Focus on Alleged Misbranding and Unapproved Route of Administration for ANKTIVA

NEW YORK, April 23, 2026 /PRNewswire/ -- SueWallSt reminds purchasers of ImmunityBio, Inc. (NASDAQ: IBRX) securities of a pending securities class action.

THE CASE: A class action seeks to recover damages for investors who purchased ImmunityBio securities between January 19, 2026 and March 24, 2026.

YOUR OPTIONS: You may be entitled to compensation without payment of any out-of-pocket fees. See if you can recover losses or contact Joseph E. Levi, Esq. at [email protected] or (888) SueWallSt.

ImmunityBio shares lost $1.98 per share, a 21% decline, closing at $7.42 on March 24, 2026, after investors learned the FDA had determined that the Company's promotional communications for its lead drug ANKTIVA were false or misleading and violated federal drug law. Investors have until May 26, 2026 to seek lead plaintiff status.

The Alleged Misbranding Under the FD&C Act

A biopharmaceutical company cannot lawfully promote a drug beyond the specific indications and routes of administration approved by the FDA. ANKTIVA received approval for intravesical use only, meaning it is administered directly into the bladder, in combination with BCG, for a narrow subset of bladder cancer patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ.

The lawsuit contends that promotional communications disseminated during the Class Period went far beyond those boundaries, describing ANKTIVA as a subcutaneous injection, a "single jab," and a "little vial that you inject subcutaneously." The FDA's Warning Letter stated that the drug's labeling specifies intravesical use only and that ANKTIVA "should not be administered by subcutaneous or intravenous or intramuscular routes." The filing states that promoting an unapproved route of administration rendered the drug misbranded under 21 U.S.C. 352(f)(1).

Alleged Unapproved Use Promotion by the Numbers

• ANKTIVA is approved for one specific type of bladder cancer; bladder cancer itself represents only 4.2% of the estimated 2,041,910 new U.S. cancer cases in 2025, as set forth in the complaint
• The promotional communications allegedly claimed the drug "can treat all cancers," vastly exceeding its single approved indication
• ANKTIVA's labeling requires intravesical administration; the promotional materials allegedly depicted and described subcutaneous injection
• A single-agent cohort (Cohort C) of the QUILT-3.032 study was stopped early for futility, yet the promotional materials allegedly suggested ANKTIVA was effective on its own as a "single jab"
• The FDA classified the promotional violations as "concerning from a public health perspective" due to the risk of patients seeking unapproved treatment
• The Company allegedly failed to submit the podcast to FDA at the time of initial dissemination, violating 21 CFR 314.81(b)(3)(i)

 failed to submit the podcast to FDA at the time of initial dissemination, violating 21 CFR 314.81(b)(3)(i)

FD&C Act Violations and Investor Harm

The action claims that by promoting ANKTIVA for unapproved uses, unapproved routes of administration, and as a cancer "vaccine" with preventative properties unsupported by clinical data, the Company exposed itself to regulatory enforcement that was foreseeable and material to investors. When the FDA's March 13, 2026 Warning Letter became public on March 24, 2026, the market repriced IBRX shares to reflect the regulatory reality that had been concealed.

Calculate your potential recovery or call (888) SueWallSt.

"The complaint raises serious questions about whether investors received accurate information regarding ImmunityBio's compliance with federal drug promotion regulations, and whether the Company's promotional strategy created foreseeable regulatory risk that was not disclosed." -- Joseph E. Levi, Esq.

ABOUT LEVI & KORSINSKY, LLP -- Over the past 20 years, Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders. The firm has extensive expertise in complex securities litigation and a team of over 70 employees. For seven consecutive years, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report.

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 became public. Investors who purchased shares during the class period at artificially inflated prices may be entitled to compensation.

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 [email protected] 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.

Q: What court was the IBRX class action filed in? A: The case was filed in the United States District Court for the Central District of California, governed by the Private Securities Litigation Reform Act of 1995.

CONTACT:
SueWallSt
Joseph E. Levi, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
[email protected]
Tel: (888) SueWallSt
Fax: (212) 363-7171

SOURCE SueWallSt.com