ImmunityBio IBRX announced that the FDA has expanded the label of its sole marketed drug, Anktiva, for a broader population in non-muscle-invasive bladder cancer (NMIBC), the most common form of bladder cancer.
The drug is now approved in combination with Bacillus Calmette-Guérin (BCG) to treat patients with BCG-unresponsive NMIBC with high-grade papillary-only disease. The decision marks the first FDA approval specifically for this patient population.
The regimen was initially approved in 2024 for the treatment of adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors.
With the expanded label, Anktiva plus BCG now covers all patients with BCG-unresponsive NMIBC.
This approval came roughly three months ahead of the FDA’s target action date of Jan. 6, 2027. The decision also marks a new approach to evaluating treatments for BCG-unresponsive NMIBC. The agency based its decision on evidence supporting Anktiva’s earlier approval for CIS, along with scientific similarities between CIS and high-grade papillary-only disease.
NMIBC accounts for approximately 80% of U.S. bladder cancer diagnoses, and an estimated 85% to 90% of NMIBC patients present with papillary disease. Given the high lifetime cost of bladder cancer care and limited nonsurgical treatment options for BCG-unresponsive high-grade papillary disease, the expansion could broaden Anktiva’s commercial opportunity.
IBRX’s Stock Performance
Year to date, the company’s shares have skyrocketed over 400% compared with the industry’s 2% growth.
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Anktiva: A Key Revenue Driver for ImmunityBio
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. In the first six months of 2026, the company reported net product revenues of approximately $95 million from Anktiva sales, which surged 121% year over year. The increase was driven by strong demand from new prescribers and broader physician adoption.
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.
Beyond bladder cancer, ImmunityBio is advancing Anktiva in non-small cell lung cancer (NSCLC), where it has secured approvals in select international markets, is pursuing a U.S. regulatory pathway and is conducting the global phase III ResQ201A study. The company is also planning a registrational study in glioblastoma and advancing an FDA RMAT-designated phase II program in pancreatic cancer.
IBRX’s Zacks Rank
ImmunityBio currently carries a Zacks Rank #3 (Hold).
ImmunityBio, Inc. Price
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Key Picks Among Biotech Stocks
A couple of better-ranked stocks in the biotech sector include Amarin AMRN and Corcept Therapeutics CORT, currently sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, loss per share estimates for Amarin have narrowed from 65 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 51 cents to 50 cents. The stock has lost 16% so far this year.
Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 62.27%.
Over the past 60 days, earnings per share estimates for Corcept Therapeutics have increased from $1.13 to $1.86 for 2026. Over the same period, estimates for 2027 earnings per share have risen from $2.35 to $3.49. The stock has surged over 230% year to date.
Corcept Therapeutics’ earnings missed estimates in two of the trailing four quarters, beat in one and met in the other, with the average surprise being 240.74%.
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This article originally published on Zacks Investment Research (zacks.com).