Full Press Release Details
ImmunityBio Addresses FDA Correspondence and Reaffirms Commitment to Advertising Compliance
Calif., April 6, 2026 - ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced it has submitted a comprehensive
response to the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) regarding issues raised on March 13, 2026 related to a television advertisement and a podcast. The company addressed the concerns related to
the podcast and informed OPDP that the television advertisement was never aired.
The response outlines the company's immediate and
planned corrective actions and its ongoing commitment to ensuring all promotional communications for ANKTIVA (nogapendekin alfa inbakicept-pmln) are accurate, balanced, and
compliant with FDA regulations.
Commitment to Advertising Compliance and Resolution
ImmunityBio has taken proactive steps to address the OPDP's concerns, including the removal of the identified podcast from its corporate website and
requesting its removal from third-party platforms. Additionally, the company confirmed that a television advertisement mentioned in the OPDP letter was never broadcast or disseminated to the public.
"ImmunityBio takes promotional compliance with the utmost seriousness," said Richard Adcock, President and CEO of ImmunityBio. "We
are dedicated to maintaining a clear distinction between our investigational pipeline aspirations and the promoted indications for our approved therapies. We believe our substantive remedial actions and enhanced internal protocols address the
Upon receipt of the letter from OPDP, ImmunityBio initiated a comprehensive review
of all promotional materials and external communications claims with its legal and regulatory teams.
The company is implementing a
robust suite of corrective actions and compliance enhancements, including mandatory executive training, expanded Promotional Review Committee (PRC) protocols, and the engagement of external regulatory counsel to audit future
high-visibility communications.
Clarifying the Context of Scientific Innovation
In its response, ImmunityBio also provided background regarding the statements cited by the Office of Prescription Drug Promotion, which
occurred during a podcast appearance by Founder and Executive Chairman Dr. Patrick Soon-Shiong. The company noted that these remarks were intended to convey Dr. Soon-Shiong's aspirational and
forward-looking opinions regarding his vision for the company's drug development pipeline and the underlying science supporting the strategy of treating patients with cancer.
Other key points of clarification include:
About ANKTIVA (nogapendekin alfa inbakicept-pmln)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system
by affecting the development, maintenance, and function of key immune cells-NK and CD8+ killer T cells-that are involved in killing cancer cells. By activating NK cells, ANKTIVA
overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This
fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
IMPORTANT SAFETY INFORMATION
USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Gu rin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with
carcinoma in situ (CIS) with or without papillary tumors.
WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed
Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.
DOSAGE AND ADMINISTRATION: For Intravesical Use
Only. Do not administer by subcutaneous or intravenous routes.
Please see the complete Indication and Important Safety Information and Prescribing
Information for ANKTIVA at Anktiva.com.
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the
patient's immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological
memory in patients. At the core of our strategy is the Cancer BioShield platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells,
cytotoxic T cells, and
memory T cells via our proprietary IL-15 superagonist. Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is
complemented by an investigational portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous
NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy. For
more information, visit ImmunityBio.com and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
Forward Looking Statements
This press release contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding our planned corrective actions and compliance enhancements. These
statements are based on the Company's current expectations, beliefs, assumptions, and plans and involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include, among others, the Company's ability to successfully execute on these corrective action and compliance enhancement plans and the reliance on the cooperation of third-parties for
certain corrective actions. More details about these and other risks that may impact ImmunityBio's business are described under the heading "Risk Factors" in the Company's
Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC's website
ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date
hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.
ImmunityBio Contacts:
Hemanth Ramaprakash, PhD, MBA