Database lock completed for Cohort A of QUILT-2.005 (NCT02138734), a randomized, controlled registrational trial comparing ANKTIVA® plus BCG with BCG alone in 366 patients with BCG-naïve non-muscle invasive bladder cancer (NMIBC)

ANKTIVA plus BCG is being evaluated as the first locally delivered, chemotherapy-free combination immunotherapy for BCG-naïve NMIBC

Final analysis of the trial’s primary efficacy endpoint is underway, with topline results expected in November 2026

Supplemental Biologics License Application (sBLA) submission remains on track for the fourth quarter of 2026, potentially expanding ANKTIVA’s indication to include patients with BCG-naïve NMIBC earlier in their disease course | $IBRX

Peer-reviewed publication reports long-term outcomes from the QUILT-3.032 study supporting durable disease control and bladder preservation | $IBRX

Expanded indication extends ANKTIVA plus BCG to patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC), including those with carcinoma in situ (CIS), with or without papillary tumors, and those with papillary-only tumors

Papillary disease represents approximately 85% of the NMIBC patient population1

This is the first FDA approval to include BCG-unresponsive NMIBC with papillary-only tumors

With this FDA approval, access to ANKTIVA plus BCG expands to include all patients with BCG-unresponsive NMIBC | $IBRX