ANKTIVA (N-803) is an ImmunityBio, Inc. program in with BCG, adults with BCG-unresponsive non-muscle invasive bladder cancer; now includes high-grade papillary-only tumors as well as CIS with or without papillary tumors. The FDA approved it on Oct 14, 2026. 2 FDA decisions on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: with BCG, adults with BCG-unresponsive non-muscle invasive bladder cancer; now includes high-grade papillary-only tumors as well as CIS with or without papillary tumors (approved Oct 14, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: ImmunityBio, Inc. (IBRX). Approval record: sBLA expanding the 2024 indication to papillary-only disease. Per the FDA, based on the prior efficacy in QUILT-3.032 Cohort A (NCT03022825; 77 patients with CIS; CR 62%, 95% CI 51 to 73) extended to high-grade papillary-only tumors on review of available scientific information. Market-cap tier at the time we tracked it: Large. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for ANKTIVA (N-803); 2 FDA decisions are on record below.
On Oct 14, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records ANKTIVA (N-803) is FDA-approved for with BCG, adults with BCG-unresponsive non-muscle invasive bladder cancer; now includes high-grade papillary-only tumors as well as CIS with or without papillary tumors (approved Oct 14, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
ImmunityBio, Inc. (IBRX).
Yes. The FDA approved an application for ANKTIVA (N-803) on Oct 14, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.