ImmunityBio Faces Investor Lawsuits After FDA Rebuke Over Marketing Claims

A promising start to the year for ImmunityBio has been abruptly overshadowed by legal and regulatory challenges. The biopharmaceutical company, whose shares had previously seen triple-digit percentage gains, is now confronting a cascade of class-action lawsuits. This follows a stern warning from the U.S. Food and Drug Administration (FDA) concerning promotional claims deemed misleading, allegations that have severely damaged investor confidence and triggered accusations of securities fraud.

Shareholder Value Evaporates in Market Selloff

The financial impact was immediate and severe. On March 24, the company's stock price plummeted by 21 percent to $7.42. This single-day decline wiped out nearly $2 billion in market capitalization, marking the most significant intraday drop for ImmunityBio shares since December 2024. The selloff represents a dramatic reversal for an equity that had appreciated by more than 250 percent since the beginning of the year.

FDA Warning Letter Sparks Legal Firestorm

The catalyst for the turmoil was an FDA warning letter made public late last week. The agency took issue with statements made by Executive Chairman Dr. Patrick Soon-Shiong. In a podcast and a television advertisement, Dr. Soon-Shiong had suggested that the bladder cancer drug Anktiva could cure and even prevent all types of cancer. The FDA clarified that no data exists to support such expansive claims.

Should investors sell immediately? Or is it worth buying ImmunityBio?

Adding to the gravity of the situation is the revelation that the FDA had sent similar admonishments to an ImmunityBio subsidiary in September 2025 and again in January 2026. Several law firms, including Block & Leviton and Rosen Law, have now filed suits. They allege that company management artificially exaggerated Anktiva's capabilities, thereby systematically misleading investors.

Core Business Operations Continue Unabated

Despite the legal turbulence, ImmunityBio's commercial activities for Anktiva continue for its approved indications. The underlying business remains operational: for the full year 2025, the company generated net product revenue of approximately $113 million from the drug. This figure constitutes a 700 percent increase over the prior year.

Furthermore, the firm submitted a supplemental marketing application for an additional bladder cancer indication in early March. This regulatory review process is proceeding independently of the current FDA reprimands.

Path Forward: Regulatory Compliance and Legal Deadlines

ImmunityBio is now obligated to respond to the FDA's demands and implement mandatory corrective measures. Concurrently, the legal front is consolidating. Affected investors have until May 26, 2026, to register as lead plaintiffs for the class-action suits with the court. As of now, ImmunityBio has not issued an official statement addressing the fraud allegations.

Ad

ImmunityBio Stock: New Analysis - 30 March

Fresh ImmunityBio information released. What's the impact for investors? Our latest independent report examines recent figures and market trends.

Read our updated ImmunityBio analysis...

US45256X1037 | IMMUNITYBIO | boerse | 69027324 |