ImmunityBio, Inc. IBRX
ImmunityBio, Inc. (Nasdaq: IBRX) is an oncology drug developer. Its lead program, ANKTIVA (nogapendekin alfa inbakicept-pmln) plus BCG, is in Phase 3 for BCG-unresponsive non-muscle invasive bladder cancer (CIS with or without Ta/T1). Its next catalyst on record is ANKTIVA + BCG (QUILT-2.005): Planned sBLA submission, BCG-naive NMIBC (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: ANKTIVA + BCG (QUILT-2.005) — Planned sBLA submission, BCG-naive NMIBC (2026). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ANKTIVA + BCG | BCG-unresponsive NMIBC with CIS | biologic-other | Approved |
| ANKTIVA sBLA (papillary NMIBC) | BCG-unresponsive papillary NMIBC | biologic-other | Phase 3 |
| ANKTIVA + BCG (QUILT-2.005) | BCG-naive NMIBC | biologic-other | Phase 3 |
| PD-L1 t-haNK | Glioblastoma | cell therapy | Phase 2 |
| ANKTIVA combination regimen | Pancreatic cancer | biologic-other | Phase 2 |
| CD19 t-haNK / CAR-NK | B-cell malignancies | cell therapy | Phase 1 |
Recent results and decisions
- Oct 14, 2026approval FDA approved the sBLA expanding ANKTIVA plus BCG to BCG-unresponsive NMIBC with papillary-only tumors, ahead of the January 6, 2027 PDUFA date; the first FDA approval covering papillary-only disease.
today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive NMIBC with papillary-only tumors.
Filing - Oct 14, 2026approval FDA expands ANKTIVA approval to include patients with BCG-unresponsive NMIBC with papillary-only tumors, the first FDA approval for this patient population.
This is the first FDA approval to include BCG-unresponsive NMIBC with papillary-only tumors.
Filing - Aug 4, 2026accepted FDA accepted the sBLA for ANKTIVA plus BCG in BCG-unresponsive papillary-only NMIBC and set a PDUFA target action date of January 6, 2027.
The FDA accepted for review the Company’s supplemental Biologics License Application (sBLA) for ANKTIVA plus BCG in patients with BCG-unresponsive NMIBC with papillary disease without CIS and assigned a PDUFA target action date of January 6, 2027
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.