Shares of ImmunityBio IBRX were up 11% on Monday after the company announced that Macau’s regulatory body has approved its lead drug, Anktiva, for treating certain patients with a type of bladder cancer.
The regulatory body has approved Anktiva in combination with Bacillus Calmette-Guérin (BCG) for treating adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
The approval was based on data from the phase II/III QUILT-3.032 study, which showed that treatment with Anktiva in combination with BCG in the given patient population led to a complete response rate of 71%, with a median duration of response of 26.6 months.
The latest nod marks the first regulatory authorization for Anktiva in Asia, underlining the company’s ongoing strategy to expand global access and establish a global commercial presence for the combo therapy.
With the approval in China, Anktiva combo therapy is now cleared in 34 countries and territories. The combo therapy was approved by the FDA in 2024 for the same indication, while it received conditional marketing authorization in the EU in February 2026. The combo therapy is also approved in the United Kingdom and Saudi Arabia.
IBRX's Price Performance
In the past six months, shares of ImmunityBio have skyrocketed 282.1% compared with the industry’s increase of 14.7%.
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IBRX's Development Activities With Anktiva
ImmunityBio’s commercial growth is currently being driven by its sole marketed drug, Anktiva. The launch trajectory of Anktiva 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.
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 in the near term, 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 NSCLC indication.
ImmunityBio, Inc. Price
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IBRX's Zacks Rank & Stocks to Consider
ImmunityBio currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Phathom Pharmaceuticals PHAT, ANI Pharmaceuticals ANIP and Replimune Group REPL, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, estimates for Phathom Pharmaceuticals’ 2026 earnings per share have increased from 23 cents to 28 cents, while the same for 2027 have increased from $2.22 to $2.25. PHAT’s shares have declined 9.3% in the past six months.
Phathom Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 14.06%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 earnings per share have increased from $8.28 to $8.99, while the same for 2027 have increased from $9.25 to $10.10. ANIP’s shares have fallen 20.8% in the past six months.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
Over the past 60 days, estimates for Replimune’s 2026 loss per share have narrowed from $3.61 to $3.40, while the same for 2027 have narrowed from $2.58 to $2.46. REPL’s shares have rallied 72.3% in the past six months.
Replimune’s earnings beat estimates in one of the trailing four quarters and missed on the remaining three occasions, with the average negative surprise being 4.46%.
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This article originally published on Zacks Investment Research (zacks.com).