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ImmunityBio stock price rises after submitting compliant response to the FDA
Investing.com – ImmunityBio (NASDAQ:IBRX) shares rose 3% on Monday, after the company submitted a comprehensive response to the U.S. Food and Drug Administration regarding alleged promotional compliance issues.
The biotechnology company responded to concerns raised by the FDA’s Office of Prescription Drug Promotion on March 13, 2026, regarding television advertisements and podcasts. ImmunityBio confirmed that the television advertisements mentioned in the FDA letter were never broadcast, aired, or disseminated to the public.
The company has removed the identified podcast from its corporate website and formally required all third-party hosting platforms to remove it. ImmunityBio has launched a comprehensive review of its promotional materials and is implementing enhanced advertising compliance measures.
ImmunityBio President and CEO Richard Adcock said: “ImmunityBio takes promotional compliance extremely seriously. We are committed to maintaining a clear boundary between the vision for our R&D pipeline and the approved treatment indications.”
The company is implementing corrective actions, including mandatory executive training, expanding the scope of the promotional review committee’s charter, and hiring external regulatory consultants to review future high-visibility communications.
In its response, ImmunityBio provided background on statements made by founder and Executive Chairman Dr. Patrick Soon-Shiong in the podcast. The company said the statements were intended to convey visionary and forward-looking views regarding the company’s drug development pipeline.
ANKTIVA has been approved for use in combination with BCG to treat adult patients with BCG-unresponsive, non–muscle-invasive bladder cancer with or without papillary carcinoma in situ.
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