ANKTIVA (N-803) + BCG was approved by the FDA on October 14, 2026 for BCG-unresponsive non-muscle invasive bladder cancer with papillary-only tumors.
The FDA approved an expanded indication for Anktiva (nogapendekin alfa inbakicept-pmln) with BCG on October 14, 2026, adding adults with BCG-unresponsive non-muscle invasive bladder cancer with high-grade papillary-only tumors to the existing CIS indication. The goal date was January 6, 2027, so the action came 84 days early. ImmunityBio announced the approval the same day.
The FDA's approval notification is dated October 14, 2026 and states the approval was made that day; it revises the 2024 indication (BCG-unresponsive NMIBC with CIS, with or without papillary tumors) to include patients with high-grade papillary-only tumors (FDA approval notification). The goal date was January 6, 2027: ImmunityBio's 8-K exhibit of August 4, 2026 says the FDA accepted the sBLA "for ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with papillary disease without CIS" and assigned that PDUFA date (ImmunityBio 8-K exhibit, August 4, 2026). Both dates come from documents that state them, so the action came 84 days before the goal date. Per the FDA, efficacy was previously shown in Cohort A of QUILT-3.032 (NCT03022825), 77 patients with BCG-unresponsive NMIBC with CIS: complete response rate 62% (95% CI 51 to 73), with 58% of responders lasting 12 months or more. The FDA extended that result to papillary-only disease on review of the available scientific information, citing the overlapping clinical features of the two tumor types, rather than on a new trial. The FDA also issued a press announcement the same day, calling Anktiva the first FDA-approved treatment specifically for patients with BCG-unresponsive, high-grade papillary-only disease (FDA press announcement, October 14, 2026). ImmunityBio announced the approval on October 14, 2026 (8-K exhibit 99.1). The FDA says full prescribing information will be posted on Drugs@FDA; the letter had not been posted there when this page was published.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval notification, nogapendekin alfa inbakicept-pmln for BCG-unresponsive NMIBC, October 14, 2026
FDA record of the action: the FDA approved on October 14, 2026, per FDA approval notification (sBLA, BLA 761336; letter not yet on Drugs@FDA) (FDA notice). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for Anktiva (nogapendekin alfa inbakicept-pmln) + BCG on October 14, 2026, per the FDA's own record. The primary source is linked on this page.
Anktiva (nogapendekin alfa inbakicept-pmln) + BCG is an ImmunityBio (IBRX) program. The FDA decision came on October 14, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), IBRX moved +19.7%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
The FDA approved nogapendekin alfa inbakicept-pmln (Anktiva, ImmunityBio) with BCG on October 14, 2026 for adults with BCG-unresponsive non-muscle invasive bladder cancer, expanding the indication to include high-grade papillary-only tumors, per the FDA's approval notification of that date. ImmunityBio had given January 6, 2027 as the goal date, so the action came 84 days early.
Per the FDA, efficacy was previously shown in Cohort A of QUILT-3.032 (NCT03022825), 77 patients with BCG-unresponsive NMIBC with carcinoma in situ, with a complete response rate of 62% (95% CI 51 to 73). The FDA extended that result to high-grade papillary-only disease on review of the available scientific information, citing the overlapping clinical features of the two tumor types.