New York, May 20, 2026, 09:07 EDT
- The FDA has accepted ImmunityBio’s supplemental application for Anktiva with BCG in papillary-only, BCG-unresponsive non-muscle invasive bladder cancer. The agency set a target action date for Jan. 6, 2027.
- ImmunityBio traded at $7.76 ahead of the open, off 2.8% from its previous close. The company’s market cap is about $8.0 billion.
- ImmunityBio, Inc. posted $44.2 million in net product revenue for the first quarter. Cash, cash equivalents and marketable securities came to $380.9 million.
ImmunityBio’s push to expand Anktiva’s use in bladder cancer is back before the FDA, after the agency accepted a supplemental biologics license application. The FDA set a target action date for Jan. 6, 2027. ImmunityBio wants approval for Anktiva used with Bacillus Calmette-Guérin, or BCG, for BCG-unresponsive non-muscle invasive bladder cancer patients with papillary disease and no carcinoma in situ.
The timing is key since the application could push Anktiva into a bigger piece of the early-stage bladder cancer space, past its current approved group. ImmunityBio said about 85% of the 64,000 or so U.S. patients diagnosed with non-muscle invasive bladder cancer each year have papillary disease.
FDA held a public workshop May 18 on trial design for non-muscle invasive bladder cancer, looking at both papillary tumors and carcinoma in situ, or CIS. The difference between the two is a key point in ImmunityBio’s filing, with the company urging regulators to accept data and biological arguments connecting them.
Non-muscle invasive bladder cancer means the cancer hasn’t reached the bladder muscle. BCG is a tuberculosis vaccine that also gets used in the bladder to trigger an immune response against some bladder tumors. A supplemental BLA asks to expand or change the approved use for a biologic drug.
Anktiva is already FDA approved with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer with CIS, including cases with or without papillary tumors. Now, the new filing is aimed at papillary-only disease. The company said those patients still don’t have many bladder-sparing choices.
ImmunityBio’s filing is based on Cohort B from the QUILT 3.032 Phase 2/3 trial, which enrolled 80 patients with high-grade papillary-only disease. The company said the study reached its primary endpoint, reporting a 12-month disease-free survival rate of 58.2%. Disease-free survival tracks patients with no recurrence or progression during that time.
ImmunityBio founder Patrick Soon-Shiong said patients with this disease have “limited treatment options.” CEO Richard Adcock said the FDA filing marks an “important milestone” for the company and called papillary-only disease the “larger segment” among BCG-unresponsive cases. ImmunityBio
Keytruda from Merck is on the market for certain BCG-unresponsive high-risk non-muscle invasive bladder cancer patients with CIS. Johnson & Johnson’s Inlexzo, which used to be called TAR-200, picked up FDA approval in 2025 for BCG-unresponsive cases with CIS and can be used whether or not papillary tumors are present. The competition isn’t thin anymore.
ImmunityBio presented new data at the American Urological Association meeting, laying out indirect comparisons of Anktiva plus BCG with nadofaragene firadenovec, Ferring’s Adstiladrin, and TAR-200. Dr. Brooke B. Edwards from The Urology Group in Cincinnati said the findings could help with “shared decision making.” The company said the analyses weren’t head-to-head trials. ImmunityBio, Inc.
Supply is another piece. ImmunityBio disclosed in a May 18 securities filing that it has an exclusive development and supply deal with Japan BCG Laboratory for the Tokyo-172 BCG strain in the U.S. and territories. No payment is required before FDA approval. The deal runs for 10 years from approval.
ImmunityBio is looking to turn its regulatory wins into real sales. The company posted first-quarter net product revenue of $44.2 million, up 168% from last year. But its net loss widened sharply to $632.8 million, as changes in fair value of warrants, derivatives and related-party note liabilities weighed results.
The filing is not an approval. ImmunityBio said the FDA will look at whether papillary disease is close enough to CIS for data from the existing label to apply, and said the agency flagged issues with single-arm studies in patients with only papillary disease; risks now include a limit on the label, more waiting, or no approval.
There’s still a regulatory cloud hanging over the stock. Back in March, the FDA sent a warning to ImmunityBio for what it called false or misleading promotion of Anktiva. Piper Sandler’s Edward Tenthoff told Reuters then he thought the company could meet the FDA’s demands and kept his revenue forecast unchanged.
The next fixed date on the calendar is Jan. 6, 2027. Between now and then, the market faces a bigger bladder-cancer play, but has to balance that against FDA questions on evidence, rivals in bladder-sparing therapies, and ImmunityBio still needing to turn Anktiva use into lasting sales.
