ImmunityBio’s Saudi Launch and Record Sales Collide With Shareholder Litigation

ImmunityBio has pulled off a remarkable feat in the Middle East, getting its immunotherapy ANKTIVA onto the Saudi Arabian market within just 60 days of signing a regional partnership for the Middle East and North Africa. The drug is now available there for patients with bladder and lung cancer, a speed of entry that underscores the pent-up demand for novel oncology treatments in the region.

The Saudi launch is part of a broader international push. ImmunityBio has also made regulatory headway in Macau and the European Union, building on the US approval it secured from the FDA in April 2024. But while the commercial story is one of rapid expansion, a very different narrative is unfolding on the legal front.

The company’s first-quarter 2026 results tell a tale of strong operational momentum. Preliminary product revenue hit roughly $44.2 million, a 168 percent jump from the same period a year earlier. That marks a record for the biotech firm and suggests ANKTIVA is gaining traction in its home market. On the balance sheet, ImmunityBio held around $381 million in cash and securities as of March 31, bolstered by $100 million in financing transactions late in the quarter — $75 million of it non-dilutive and earmarked for global commercialization.

Yet those numbers are being overshadowed by a legal storm. The trouble began when the FDA sent a warning letter in March, accusing management of making misleading promotional claims about ANKTIVA. The trigger was a nationally broadcast podcast featuring the company’s board chairman. When the FDA’s rebuke became public on March 24, the market reacted swiftly: ImmunityBio’s shares collapsed from $9.40 to $7.42 in a single session.

Shareholders have now mobilized. Two law firms are preparing class-action lawsuits, and investors who believe they were misled have until May 26 to apply for lead plaintiff status in California. The legal filings argue that the stock’s plunge represented the bursting of an artificially inflated bubble.

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

A particularly damaging detail in the FDA’s letter revealed that the agency had sent two similar warnings to an ImmunityBio subsidiary the previous year. Despite those earlier alerts, the company continued promoting the drug in the same manner, according to the complaint. The result has been a sharp erosion of investor trust.

ImmunityBio has since tried to contain the damage. In early April, it submitted a comprehensive response to the FDA. The controversial podcast has been taken down, and the company says the TV ad that drew criticism was never actually aired. Management has also pledged to tighten internal compliance procedures.

On the clinical side, the pivotal QUILT-2.005 trial evaluating ANKTIVA in BCG-naive patients with non-muscle invasive bladder cancer has completed enrollment. ImmunityBio plans to file a supplemental approval application with the FDA later this year.

For now, the company’s trajectory is defined by a sharp divergence: record commercial performance and a promising pipeline on one side, and a regulatory and legal overhang on the other. With the May 26 class-action deadline approaching, the legal risk is likely to keep weighing on the stock, even as the underlying business continues to grow.