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IBRX Stock Slides on FDA Warning Over Misleading Cancer Drug Claims
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Key Takeaways
IBRX shares fell over 21% after FDA warning over false or misleading Anktiva promotions.
FDA cited "cancer vaccine" claims, off-label breadth and weak risk disclosure; response due in 15 days.
ImmunityBio's Anktiva drives growth, with 2025 revenues up ~700% to $113M amid expansion efforts.
Shares of ImmunityBio (IBRX - Free Report) fell more than 21% on Tuesday after the FDA issued a warning letter over “false” or “misleading” promotional statements related to the company’s cancer drug Anktiva.
What Triggered the FDA Warning for IBRX?
The warning letter, issued on March 13 (and posted online on March 24), centered on promotional materials for Anktiva, including a television advertisement and a podcast featuring company executives. Per the FDA, these communications made unsupported and misleading claims about the drug’s potential, creating the impression that it could treat or even prevent multiple types of cancer.
The agency noted that the materials failed to adequately present safety risks, resulting in an imbalanced benefit-risk profile — a key violation under promotional guidelines.
In addition, the FDA flagged statements that portray Anktiva as a “cancer vaccine” or broad-based therapy across multiple oncology indications — claims that go well beyond its current label. The FDA emphasized that the drug is an IL-15 receptor agonist approved only 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.
The FDA has directed ImmunityBio to cease or correct the misleading content and submit a response within 15 days outlining how it will address the violations. A Reuters article stated that the company intends to respond within this timeframe.
This is not the first time the agency has raised concerns about Anktiva’s promotion. It previously issued untitled letters in September 2025 and January 2026, highlighting similar issues.
IBRX Stock’s Performance
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.
IBRX reported net product revenues of $113 million in 2025, up around 700% year over year. Per the company, 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 lost 1% 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 $8.28 to $8.99, while the same for 2027 have risen from $9.25 to $10.10. The stock has declined 7% 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 Stock Slides on FDA Warning Over Misleading Cancer Drug Claims
Key Takeaways
Shares of ImmunityBio (IBRX - Free Report) fell more than 21% on Tuesday after the FDA issued a warning letter over “false” or “misleading” promotional statements related to the company’s cancer drug Anktiva.
What Triggered the FDA Warning for IBRX?
The warning letter, issued on March 13 (and posted online on March 24), centered on promotional materials for Anktiva, including a television advertisement and a podcast featuring company executives. Per the FDA, these communications made unsupported and misleading claims about the drug’s potential, creating the impression that it could treat or even prevent multiple types of cancer.
The agency noted that the materials failed to adequately present safety risks, resulting in an imbalanced benefit-risk profile — a key violation under promotional guidelines.
In addition, the FDA flagged statements that portray Anktiva as a “cancer vaccine” or broad-based therapy across multiple oncology indications — claims that go well beyond its current label. The FDA emphasized that the drug is an IL-15 receptor agonist approved only 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.
The FDA has directed ImmunityBio to cease or correct the misleading content and submit a response within 15 days outlining how it will address the violations. A Reuters article stated that the company intends to respond within this timeframe.
This is not the first time the agency has raised concerns about Anktiva’s promotion. It previously issued untitled letters in September 2025 and January 2026, highlighting similar issues.
IBRX Stock’s Performance
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.
IBRX reported net product revenues of $113 million in 2025, up around 700% year over year. Per the company, 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 lost 1% 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 $8.28 to $8.99, while the same for 2027 have risen from $9.25 to $10.10. The stock has declined 7% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.