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Nogapendekin alfa inbakicept: the briefings and the record

Every Prognyx briefing on nogapendekin alfa inbakicept, newest first, and the dated events drawn from the sources those briefings cite. Rebuilt with each new briefing.

Also known as
Anktiva, NAI, N-803
Target, as briefed
IL-15 superagonist (NK/T-cell activator)
Companies named
ImmunityBio, Inc., Altor BioScience, LLC
Prognyx coverage
2 briefings, 15 October 2026 to 10 November 2026

Prognyx briefings on nogapendekin alfa inbakicept

  1. BCG-naive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situImmunityBio's ANKTIVA meets primary endpoint in BCG-naive bladder cancer trial

    The IL-15 receptor agonist plus BCG beat BCG alone on the primary endpoint in the 370-patient randomized QUILT-2.005 trial, and ImmunityBio targets a Q4 2026 supplemental BLA to move into the first-line NMIBC population.

  2. BCG-unresponsive non-muscle invasive bladder cancer (expanded indication)FDA expands ImmunityBio's Anktiva label to papillary-only NMIBC

    The 14 October approval adds high-grade papillary-only tumors to the Anktiva plus BCG label, a group ImmunityBio puts at roughly 85% of non-muscle invasive bladder cancer.

Sourced timeline

Readouts, regulatory actions, filings, trial starts and deals that the Prognyx engine extracted from the documents cited in these briefings, newest first. Each links to its source and to the briefing that cited it. Press coverage is left out, and so is any event dated on its own briefing's day: the briefing above is the record for that day. A month without a day is a date the source gave only to the month.

  1. Regulatory actionIsraeli Ministry of Health approves ANKTIVA + BCG for BCG-unresponsive NMIBC with CISImmunityBio newsroom · cited in ImmunityBio's ANKTIVA meets primary endpoint in BCG-naive bladd…
  2. ReadoutQUILT-2.005 Cohort A meets primary efficacy endpointSEC 8-K Exhibit 99.1 (press release) · cited in ImmunityBio's ANKTIVA meets primary endpoint in BCG-naive bladd…
  3. ReadoutJournal of Urology publishes long-term QUILT-3.032 outcomesSEC 8-K Exhibit 99.1 (Q3 2026 earnings release) · cited in ImmunityBio's ANKTIVA meets primary endpoint in BCG-naive bladd…
  4. Regulatory actionFDA approves expanded ANKTIVA label to papillary-only BCG-unresponsive NMIBCFDA · cited in FDA expands ImmunityBio's Anktiva label to papillary-only NMIBC
  5. Regulatory actionUAE approval for ANKTIVA + BCG (CIS and papillary NMIBC)SEC 8-K Ex-99.1 (2026-07-30) · cited in FDA expands ImmunityBio's Anktiva label to papillary-only NMIBC
  6. Regulatory actionMacau SAR approval for ANKTIVA + BCG (BCG-unresponsive NMIBC CIS)SEC 8-K Ex-99.1 (2026-03-31) · cited in FDA expands ImmunityBio's Anktiva label to papillary-only NMIBC
  7. ReadoutPivotal papillary NMIBC data (NEJM Evidence): DFS 55%/51%/48%, 93% cystectomy avoidanceSEC 8-K Ex-99.1 (2025-04-15) · cited in FDA expands ImmunityBio's Anktiva label to papillary-only NMIBC
  8. FilingImmunityBio completes sBLA submission for ANKTIVA in papillary NMIBCSEC 8-K Ex-99.1 (2025-04-15) · cited in FDA expands ImmunityBio's Anktiva label to papillary-only NMIBC
  9. Regulatory actionFDA original approval: ANKTIVA + BCG for BCG-unresponsive NMIBC with CISCompany press release (8-K Ex-99.1) · cited in FDA expands ImmunityBio's Anktiva label to papillary-only NMIBC
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Prognyx briefings are built from public information and reflect Prognyx's analysis. They are not investment advice and do not promote any product or off-label use. Event titles are written by the Prognyx engine from the linked source; the source is the record.