12-Month Ph 2 Interim Data for NDV-01 in NMIBC Reported
“These 12-month data show the potential durability of NDV-01’s clinical response profile while continuing to demonstrate a clean safety profile,” said Raj S. Pruthi, MD, Chief Medical Officer-Oncology of Relmada Therapeutics. “Importantly, we continue to observe strong responses in patients with BCG-unresponsive disease, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. We believe these interim results provide meaningful clinical validation of the program and support advancing NDV-01 into the registrational Phase 3 RESCUE program with two separate registrational pathways: 2L BCG-unresponsive and adjuvant intermediate-risk, which we expect to initiate in mid-2026.”
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