A significant regulatory warning from the U.S. Food and Drug Administration (FDA) has triggered a sharp sell-off in ImmunityBio shares. The stock plummeted more than 25% at one point during Tuesday’s trading session following the agency’s action.
The Core of the FDA’s Complaint
The FDA issued a formal reprimand to the biotechnology firm over its promotional activities for the bladder cancer drug ANKTIVA. According to the regulator, the company’s television advertisements and podcast appearances improperly presented the therapy as a potential universal cure for all cancer types. This marketing, the FDA stated, created a public health risk by going far beyond the drug’s actual approved use.
ANKTIVA is specifically sanctioned for a narrowly defined patient group: those with BCG-resistant non-muscle invasive bladder cancer carcinoma in situ. The warning letter explicitly cited statements made by Executive Chairman Dr. Patrick Soon-Shiong and CEO Richard Adcock as central examples of the violations.
A Pattern of Marketing Violations
This incident marks the third such warning for ImmunityBio in a short period. Previous communications regarding marketing compliance failures were sent in September 2025 and January 2026, targeting both ImmunityBio and its subsidiary, Altor BioScience. The company now has 15 business days to formally respond to the latest letter and submit a comprehensive correction plan to the agency.
Should investors sell immediately? Or is it worth buying ImmunityBio?
Analyst Perspective Amid the Turmoil
Despite the severe market reaction, some analysts maintain a constructive view. D. Boral Capital reaffirmed its buy rating on Monday, confirming a price target of $23.00 per share. The firm’s researchers pointed to the underlying therapeutic potential of ImmunityBio’s IL-15 superagonist platform, characterizing the marketing issues as a short-term obstacle.
The company’s operational backdrop presents a mixed picture. Recent developments include the National Comprehensive Cancer Network’s decision to add ANKTIVA to its treatment guidelines for papillary NMIBC on March 17. This was followed by the therapy’s first Asian approval in Macau on March 20. Furthermore, the ongoing QUILT-3.078 Phase 2 trial continues to evaluate ANKTIVA in a chemotherapy-free immunotherapy combination for recurrent glioblastoma.
The immediate challenge, however, remains regulatory. Three formal warnings from the FDA within six months suggest a persistent issue, and investors are now clearly pricing in the risk of a protracted conflict with the authority.
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