Shares of ImmunityBio IBRX were up 3% in after-market trading yesterday after the company announced that the FDA accepted its regulatory filing seeking to expand the use of its sole marketed drug, Anktiva.
This filing seeks the agency’s nod for the therapy, in combination with Bacillus Calmette-Guérin (“BCG”), to treat patients with BCG-unresponsive, non-muscle-invasive bladder cancer (NMIBC) with papillary-only disease. A final decision is expected by Jan. 6, 2027.
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. A potential label expansion could broaden the therapy’s eligible patient population and strengthen ImmunityBio’s foothold in the bladder cancer space.
More on IBRX’s Anktiva Filing
The FDA’s acceptance marks a key regulatory milestone for ImmunityBio, which initially submitted the application last year. At that time, the FDA refused to review the filing and requested additional data related to the use of Anktiva plus BCG in papillary-only disease.
Following discussions with the FDA, ImmunityBio resubmitted the application with updated clinical data and longer-term follow-up results. The company’s submission is supported by data from a phase II/III study evaluating Anktiva plus BCG in 80 patients with high-grade papillary-only NMIBC.
The study met its primary endpoint, demonstrating a 12-month disease-free survival (DFS) rate of 58.2%. Per the company, the data also showed durable bladder preservation benefits in treated patients.
The company also highlighted a broader scientific rationale supporting the filing. According to ImmunityBio, discussions at a recent FDA workshop and published literature suggest that papillary-only disease and CIS share similar biological characteristics and treatment approaches, which could support expanding Anktiva’s label in papillary-only disease.
IBRX’s Stock Performance
Shares of ImmunityBio have skyrocketed 292% against the industry’s 3% fall.
Image Source: Zacks Investment Research
Anktiva Drives ImmunityBio’s Growth Story
ImmunityBio’s revenue growth is currently being driven by Anktiva, an IL-15 receptor agonist that serves as the company’s lead commercial product and primary growth driver.
Earlier this month, the company reported net product revenues of approximately $44.2 million from Anktiva sales, which surged 168% year over year and 15% sequentially. The increase was driven by strong demand from new prescribers and broader physician adoption.
Recently, ImmunityBio announced that it received five patents in the United States for Anktiva, which extend protection for the company’s bladder cancer franchise through 2035.
ImmunityBio is pursuing additional label expansion opportunities for Anktiva. 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 for 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 and Indivior Pharmaceuticals INDV, each currently sporting a Zacks Rank #1 (Strong Buy) at present. 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 17% 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 3% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.
Radical New Technology Could Hand Investors Huge Gains
Quantum Computing is the next technological revolution, and it could be even more advanced than AI.
While some believed the technology was years away, it is already present and moving fast. Large hyperscalers, such as Microsoft, Google, Amazon, Oracle, and even Meta and Tesla, are scrambling to integrate quantum computing into their infrastructure.
Senior Stock Strategist Kevin Cook reveals 7 carefully selected stocks poised to dominate the quantum computing landscape in his report, Beyond AI: The Quantum Leap in Computing Power .
Kevin was among the early experts who recognized NVIDIA's enormous potential back in 2016. Now, he has keyed in on what could be "the next big thing" in quantum computing supremacy. Today, you have a rare chance to position your portfolio at the forefront of this opportunity.
See Top Quantum Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Immunocore Holdings PLC Sponsored ADR (IMCR): Free Stock Analysis Report
ImmunityBio, Inc. (IBRX): Free Stock Analysis Report
Indivior Pharmaceuticals Inc. (INDV): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).