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ImmunityBio Secures Five U.S. Patents for Anktiva in Bladder Cancer
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Key Takeaways
ImmunityBio secured five U.S. patents for Anktiva plus BCG in NMIBC through 2035.
IBRX reported $44.2M in Anktiva sales, up 168% year over year on strong physician demand.
ImmunityBio is advancing Anktiva studies in bladder cancer and other hard-to-treat tumors.
ImmunityBio (IBRX - Free Report) announced that it has received five patents in the United States covering the combination of its sole marketed drug, Anktiva, with Bacillus Calmette-Guérin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC). These patents extend protection for the company’s bladder cancer franchise through 2035.
The patent portfolio covers multiple aspects of the therapy, including methods of treating NMIBC (including BCG-naïve disease), pharmaceutical compositions, dosing regimens and the company’s two-vial commercial kit.
The development is significant for ImmunityBio as the company continues to strengthen Anktiva’s intellectual property position, given the drug’s strong commercial uptake in the United States since its 2024 approval.
Recently, the company reported net product revenues of about $44.2 million from Anktiva sales, up 168% year over year and 15% sequentially, driven by strong demand from new prescribers and broader physician adoption.
The expanded patent protection also aligns with ImmunityBio’s recently announced exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo-172 BCG strain. This deal provides the company with a second potential supply source for BCG, an important step given the persistent BCG shortages in the United States.
Currently, the therapy is approved by the FDA in combination with BCG for the treatment of adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The new patents may help ImmunityBio defend Anktiva’s market exclusivity, as it pursues additional label expansions.
IBRX’s Stock Performance
Shares of ImmunityBio have skyrocketed more than 300% against the industry’s 2% fall.
Image Source: Zacks Investment Research
IBRX's Development Activities With Anktiva
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 30 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. Over the same period, estimates for 2027 have improved from a loss of 39 cents to earnings of 11 cents. IMCR shares have lost 18% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 30 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV shares have risen 2% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.
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ImmunityBio Secures Five U.S. Patents for Anktiva in Bladder Cancer
Key Takeaways
ImmunityBio (IBRX - Free Report) announced that it has received five patents in the United States covering the combination of its sole marketed drug, Anktiva, with Bacillus Calmette-Guérin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC). These patents extend protection for the company’s bladder cancer franchise through 2035.
The patent portfolio covers multiple aspects of the therapy, including methods of treating NMIBC (including BCG-naïve disease), pharmaceutical compositions, dosing regimens and the company’s two-vial commercial kit.
The development is significant for ImmunityBio as the company continues to strengthen Anktiva’s intellectual property position, given the drug’s strong commercial uptake in the United States since its 2024 approval.
Recently, the company reported net product revenues of about $44.2 million from Anktiva sales, up 168% year over year and 15% sequentially, driven by strong demand from new prescribers and broader physician adoption.
The expanded patent protection also aligns with ImmunityBio’s recently announced exclusive U.S. development and supply agreement with Japan BCG Laboratory for the Tokyo-172 BCG strain. This deal provides the company with a second potential supply source for BCG, an important step given the persistent BCG shortages in the United States.
Currently, the therapy is approved by the FDA in combination with BCG for the treatment of adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. The new patents may help ImmunityBio defend Anktiva’s market exclusivity, as it pursues additional label expansions.
IBRX’s Stock Performance
Shares of ImmunityBio have skyrocketed more than 300% against the industry’s 2% fall.
Image Source: Zacks Investment Research
IBRX's Development Activities With Anktiva
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 Immunocore (IMCR - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. Over the same period, estimates for 2027 have improved from a loss of 39 cents to earnings of 11 cents. IMCR shares have lost 18% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.
Over the past 30 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV shares have risen 2% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.