Scrutiny Over FDA Communications Weighs on ImmunityBio Shares

ImmunityBio US45256X1037

ImmunityBio, a company specializing in immunotherapies, is facing investor scrutiny. Recent reports allege that Chairman Patrick Soon-Shiong may have mischaracterized communications with the U.S. Food and Drug Administration (FDA). This development emerges alongside a mixed operational picture: a regulatory setback for a key cancer drug was recorded in May 2025, while progress continues in other clinical trials.

The controversy centers on the planned label expansion for the cancer drug ANKTIVA. The therapy was seeking approval for treating BCG-resistant non-muscle invasive bladder cancer with papillary tumors. In May 2025, the FDA issued a "Refusal to File" letter for this supplemental application, halting its review.

A report from STAT News on January 29, 2026, states the FDA's refusal was based on non-persuasive clinical data and violations of regulatory guidelines. This account contradicts the company's initial characterization, which suggested the agency had merely requested additional information. Following the rejection, ImmunityBio stated it would submit the required data within 30 days and that new clinical studies would not be necessary.

Clinical Progress in Other Areas

Despite these U.S. regulatory challenges, positive developments have occurred elsewhere. Saudi Arabia's drug authority approved ANKTIVA for certain forms of bladder cancer in January 2026. The drug is already approved in the United States for patients with bladder carcinoma in situ.

Separately, on January 23, 2026, ImmunityBio released promising Phase 2 data for a chemotherapy-free treatment regimen in recurrent glioblastoma, a highly aggressive brain cancer. Of 23 enrolled patients, 19 were still alive as of the January 22 data cutoff. The median overall survival had not yet been reached at that time.

Financial Maneuvers and Market Impact

The company has also taken steps to adjust its financial structure. On January 26, 2026, terms were modified for a $505 million convertible note. The amendment allows the creditor to convert portions of the principal into stock at any time before maturity. This move follows previously reported significant year-over-year revenue growth.

Earlier in 2026, a combination of strong clinical data in other tumor types and robust revenue growth had propelled the company's shares upward. The newly surfaced allegations concerning the FDA communications, however, are likely to pressure investor confidence. The key factors moving forward will be the FDA's assessment of the forthcoming data submissions and whether the allegations against Soon-Shiong are substantiated.