nogapendekin alfa inbakicept-pmln (ANKTIVA) — FDA meeting
2026
Discussions planned with the U.S. FDA in 2026 for the accelerated approval pathwaySource filing
IBRX biotech catalysts & pipeline
IMMUNITYBIO INC · Data as of 2026-09-08
Upcoming catalysts
nogapendekin alfa inbakicept-pmln (ANKTIVA) — NDA/BLA submission
2026
Continued advancement across the clinical pipeline, with multiple anticipated regulatory, clinical, and data milestones expected over the next 12 months, including a planned 2026 sBLA submission for the Phase 2B QUILT-2.005 trial in BCG-naïve NMIBC carcinoma in situ (with or without papillary disease)Source filing
nogapendekin alfa inbakicept-pmln (ANKTIVA) — PDUFA
Jan 6
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, 2027Source filing