ImmunityBio (IBRX) shares declined on May 29, 2026. The U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental application to expand the use of the bladder cancer drug ANKTIVA.
Agency scrutiny focuses on the extrapolation of data between different types of bladder cancer. Regulators also expressed concern regarding the company's reliance on single-arm trial evidence.
Ongoing securities class action lawsuits intensified selling pressure on the stock. These legal challenges stem from a previous FDA warning letter regarding the company's promotional statements. Investors are reassessing the company's risk profile as regulatory and legal hurdles overshadow the application review.