ImmunityBio Submits Response to FDA Addressing Advertisement Issues
ImmunityBio 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. 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 Agency's concerns."
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- Immune Cell Findings: Founder Patrick Soon-Shiong highlighted on social media that low immune cell levels are linked to over a 2-fold increase in breast cancer recurrence risk, reinforcing the scientific rationale for Anktiva and potentially advancing its application in breast cancer treatment.
- Post-COVID Research: Anktiva is currently undergoing a Phase 2 clinical trial to evaluate its efficacy in patients with persistent post-COVID symptoms, aiming to address underlying immune dysfunction by restoring immune cell balance, which could significantly reduce recurrence risk and showcase its potential in new therapeutic areas.
- Cancer Indication Expansion: Approved in 2024 for certain bladder cancer patients, Anktiva is now being studied for multiple cancers including non-small cell lung cancer and pancreatic cancer, indicating its broad indication potential that could lead to new revenue streams for the company.
- Market Sentiment Analysis: While retail sentiment for IBRX remains neutral, the stock has surged over 230% in the past year, reflecting optimistic market expectations for its future developments, particularly in applications for long COVID patients.
- Class Action Notice: Robbins LLP reminds investors of a class action filed on behalf of shareholders who purchased ImmunityBio (NASDAQ: IBRX) securities between January 19 and March 25, 2026, aimed at protecting investor rights and seeking compensation.
- FDA Warning Letter Exposed: The complaint alleges that CEO Soon-Shiong materially overstated the capabilities of the lead product ANKTIVA, with a March 24, 2026 FDA warning letter indicating misleading claims that ANKTIVA could cure and prevent all cancers.
- Significant Stock Drop: Following the FDA warning letter, ImmunityBio's common stock fell by 21%, losing $1.98 per share to close at $7.42 on March 24, 2026, reflecting market concerns about the company's future prospects.
- Shareholder Action Guidance: Shareholders can submit documents by May 26, 2026, to apply as lead plaintiffs in the class action, representing other shareholders in the litigation, while those who choose not to participate can remain absent class members eligible for recovery.

- Legal Investigation Launched: Lowey Dannenberg P.C. is investigating ImmunityBio Inc. for potential violations of federal securities laws, focusing on the accuracy and completeness of information disclosed to investors.
- Lawsuit Background: A complaint filed on March 26, 2026, alleges that ImmunityBio and its executives misrepresented Anktiva's capabilities, resulting in materially false and misleading statements about the company's business and prospects.
- Investor Losses: Attorney Andrea Farah indicated that investors who suffered losses exceeding $100,000 in ImmunityBio securities are encouraged to contact them to learn about eligibility for participation, highlighting potential legal liabilities and a decline in investor confidence.
- Reputational Risk: This investigation could negatively impact ImmunityBio's market performance, particularly as the company faces legal challenges, potentially leading to diminished investor confidence in its future business outlook.
- Lawsuit Background: ImmunityBio, Inc. (IBRX) is facing a securities fraud class action lawsuit for material misstatements and omissions regarding its lead biologic product, Anktiva, during the period from January 19 to March 24, 2026, which has shaken investor confidence.
- Stock Price Drop: Following an FDA warning on March 24, 2026, regarding misleading claims about Anktiva, ImmunityBio's stock plummeted by 21.12%, closing at $7.42 per share, reflecting significant market concerns about the company's future prospects.
- Investor Action: Affected investors are urged to file for lead plaintiff status by May 26, 2026, to represent other investors in the lawsuit, indicating a crisis of trust in the company's management.
- Legal Support: Kessler Topaz Meltzer & Check, LLP is offering free consultations and encouraging investors to reach out for more information on how to participate in the lawsuit, demonstrating a commitment to protecting investor rights.
- Trump's Policy Support: Founder Patrick Soon-Shiong stated that Trump “can make huge advances in transforming the health of Americans” following a White House push for psychedelic therapy research, potentially enhancing Anktiva's market acceptance.
- Breast Cancer Recurrence Risk Data: Soon-Shiong highlighted evidence linking lymphopenia to over a 2x increased risk of recurrence in early-stage breast cancer patients, emphasizing the importance of monitoring lymphocyte counts, which could drive clinical applications of related treatments.
- Post-COVID Immune Function Research: Plans for further clinical trials are underway to explore whether post-COVID immune dysfunction associated with T-cell exhaustion can be reversed, with Anktiva, an IL-15-based immunotherapy, potentially playing a key role in this process.
- Improved Market Sentiment: Following the news, retail sentiment for IBRX shifted from 'bearish' to 'neutral', with message volumes increasing by 70% over the week, indicating growing investor confidence in Anktiva's future potential.
- Lawsuit Background: Bronstein, Gewirtz & Grossman LLC has filed a class action lawsuit against ImmunityBio, Inc. (NASDAQ: IBRX) and certain officers, aiming to recover damages for investors who purchased securities between January 19 and March 24, 2026, reflecting strong investor concerns over potential fraud.
- Allegations: The complaint alleges that the defendants materially overstated Anktiva's capabilities and failed to disclose adverse facts regarding the company's business and prospects, which could severely undermine investor confidence and lead to significant stock price volatility.
- Investor Action: Affected investors are encouraged to apply to be lead plaintiffs by May 26, 2026, to share in any potential recovery from the lawsuit, indicating active participation and protection of their rights in the legal process.
- Law Firm's Strength: Bronstein, Gewirtz & Grossman LLC is recognized for recovering hundreds of millions for investors, emphasizing its expertise in securities fraud class actions, aiming to restore investor capital and ensure corporate accountability, thereby enhancing overall market integrity.










