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 sBLA (papillary NMIBC): FDA PDUFA target action date (January 6, 2027).
Upcoming catalysts
- January 6, 2027ANKTIVA sBLA (papillary NMIBC) — FDA PDUFA target action date
assigned a PDUFA target action date of January 6, 2027
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 - 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 - Jul 29, 2026approval Ex-US action: United Arab Emirates Emirates Drug Establishment granted marketing authorization for ANKTIVA in BCG-unresponsive NMIBC (CIS and papillary disease) and metastatic NSCLC after checkpoint failure.
today announced that the Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has granted Marketing Authorization for ANKTIVA® (nogapendekin alfa inbakicept) across two indications.
Filing
6 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
- Merck & Co., Inc. MRK
- Astrazeneca PLC AZN
- Bristol Myers Squibb Co BMY
- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- 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.