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ImmunityBio stated that it has submitted a comprehensive response to the FDA, outlining plans to implement “enhanced advertising compliance measures” for Anktiva's promotional materials. Upon receiving the warning letter, the company initiated a broad review of its promotional materials and external communications in coordination with its legal and regulatory teams.
As part of its response, ImmunityBio is rolling out a series of corrective actions and compliance enhancements. These include mandatory executive training, expanded Promotional Review Committee (PRC) protocols and the engagement of external regulatory counsel to audit future high-visibility communications.
The company issued clarifications on several matters raised by the FDA. IBRX has removed the podcast referenced in the warning letter from its website and requested its removal from third-party platforms. The company noted that the television advertisement cited by the agency was never aired. The FDA stated in its letter that these communications made unsupported and misleading claims about Anktiva’s potential, creating the impression that it could treat or even prevent multiple types of cancer.
ImmunityBio added that statements describing Anktiva as a “cancer vaccine” or as a broad-based therapy across multiple oncology indications were made in the context of its investigational use.
An IL-15 receptor agonist, Anktiva is currently approved in combination with BCG to treat adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
IBRX’s Stock Performance
Shares of ImmunityBio declined 3% on Monday, likely as investors questioned management’s judgment around promotional communications.
Year to date, shares of ImmunityBio have skyrocketed more than 250% compared with the industry’s 0.4% growth.
Image Source: Zacks Investment Research
IBRX's Development Activities With Anktiva
ImmunityBio’s commercial growth is currently being driven by Anktiva, which is its sole marketed drug. The launch trajectory of the drug has been impressive since its approval in 2024.
The company reported net product revenues of $113 million in 2025, up around 700% year over year. Per IBRX, repeat prescribing has been a major driver of sales growth, suggesting increased confidence among physicians in the drug’s efficacy and safety profile. We expect this momentum to continue in future quarters. Another factor supporting demand is the ongoing BCG shortage, which has created treatment bottlenecks in bladder cancer care. Since Anktiva is used in combination with BCG, physicians are increasingly prioritizing high-value treatment regimens for eligible patients.
ImmunityBio is pursuing additional label expansion opportunities for Anktiva. It recently resubmitted a supplemental regulatory filing with the FDA seeking label expansion for the combination of Anktiva and BCG in BCG-unresponsive NMIBC with papillary disease.
Within bladder cancer, IBRX is advancing a randomized study evaluating Anktiva plus BCG in BCG-naïve NMIBC patients — a significantly larger population than the currently approved setting. The company is targeting a potential regulatory filing later this year, with additional studies exploring the therapy across other disease settings that could further expand its addressable market.
Beyond bladder cancer, ImmunityBio is exploring Anktiva in combination with standard-of-care therapies and CAR-NK approaches across several difficult-to-treat cancers, including non-small cell lung cancer (NSCLC), pancreatic cancer, glioblastoma, colorectal cancer and hepatocellular carcinoma. In January, the therapy received its first regulatory approval in the NSCLC indication in Saudi Arabia. The company intends to hold discussions with the FDA later this year, seeking label expansion for the drug in a similar indication.
IBRX’s Zacks Rank
ImmunityBio currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.87, while those for 2027 have increased from $2.85 to $3.25. CPRX shares have risen 7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.14 to $8.99, while those for 2027 have risen from $9.25 to $10.10. The stock has declined 2% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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IBRX Responds to FDA Warning Over Misleading Cancer Drug Claims
Key Takeaways
ImmunityBio (IBRX - Free Report) announced its response to a warning letter issued by the FDA last month over “false” or “misleading” promotional statements related to its cancer drug, Anktiva.
ImmunityBio stated that it has submitted a comprehensive response to the FDA, outlining plans to implement “enhanced advertising compliance measures” for Anktiva's promotional materials. Upon receiving the warning letter, the company initiated a broad review of its promotional materials and external communications in coordination with its legal and regulatory teams.
As part of its response, ImmunityBio is rolling out a series of corrective actions and compliance enhancements. These include mandatory executive training, expanded Promotional Review Committee (PRC) protocols and the engagement of external regulatory counsel to audit future high-visibility communications.
The company issued clarifications on several matters raised by the FDA. IBRX has removed the podcast referenced in the warning letter from its website and requested its removal from third-party platforms. The company noted that the television advertisement cited by the agency was never aired. The FDA stated in its letter that these communications made unsupported and misleading claims about Anktiva’s potential, creating the impression that it could treat or even prevent multiple types of cancer.
ImmunityBio added that statements describing Anktiva as a “cancer vaccine” or as a broad-based therapy across multiple oncology indications were made in the context of its investigational use.
An IL-15 receptor agonist, Anktiva is currently approved in combination with BCG to treat adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
IBRX’s Stock Performance
Shares of ImmunityBio declined 3% on Monday, likely as investors questioned management’s judgment around promotional communications.
Year to date, shares of ImmunityBio have skyrocketed more than 250% compared with the industry’s 0.4% growth.
Image Source: Zacks Investment Research
IBRX's Development Activities With Anktiva
ImmunityBio’s commercial growth is currently being driven by Anktiva, which is its sole marketed drug. The launch trajectory of the drug has been impressive since its approval in 2024.
The company reported net product revenues of $113 million in 2025, up around 700% year over year. Per IBRX, repeat prescribing has been a major driver of sales growth, suggesting increased confidence among physicians in the drug’s efficacy and safety profile. We expect this momentum to continue in future quarters. Another factor supporting demand is the ongoing BCG shortage, which has created treatment bottlenecks in bladder cancer care. Since Anktiva is used in combination with BCG, physicians are increasingly prioritizing high-value treatment regimens for eligible patients.
ImmunityBio is pursuing additional label expansion opportunities for Anktiva. It recently resubmitted a supplemental regulatory filing with the FDA seeking label expansion for the combination of Anktiva and BCG in BCG-unresponsive NMIBC with papillary disease.
Within bladder cancer, IBRX is advancing a randomized study evaluating Anktiva plus BCG in BCG-naïve NMIBC patients — a significantly larger population than the currently approved setting. The company is targeting a potential regulatory filing later this year, with additional studies exploring the therapy across other disease settings that could further expand its addressable market.
Beyond bladder cancer, ImmunityBio is exploring Anktiva in combination with standard-of-care therapies and CAR-NK approaches across several difficult-to-treat cancers, including non-small cell lung cancer (NSCLC), pancreatic cancer, glioblastoma, colorectal cancer and hepatocellular carcinoma. In January, the therapy received its first regulatory approval in the NSCLC indication in Saudi Arabia. The company intends to hold discussions with the FDA later this year, seeking label expansion for the drug in a similar indication.
IBRX’s Zacks Rank
ImmunityBio currently carries a Zacks Rank #3 (Hold).
ImmunityBio, Inc. Price
ImmunityBio, Inc. price | ImmunityBio, Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Catalyst Pharmaceuticals (CPRX - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While CPRX sports a Zacks Rank #1 (Strong Buy) at present, ANIP carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.87, while those for 2027 have increased from $2.85 to $3.25. CPRX shares have risen 7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.14 to $8.99, while those for 2027 have risen from $9.25 to $10.10. The stock has declined 2% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.