Relmada Therapeutics Receives Written Feedback from FDA Regarding NDV-01 In Second-Line Refractory, High-Grade BCG-Unresponsive Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ
Benzinga Newsdesk 9 months ago
BiotechNewsHealth CareFDAGeneral
In its written response to Relmada's Type B pre-IND submission, the FDA indicated that a single-arm, open-label clinical trial in this high-grade, BCG-unresponsive with CIS population is an appropriate registrational
In its written response to Relmada's Type B pre-IND submission, the FDA indicated that a single-arm, open-label clinical trial in this high-grade, BCG-unresponsive with CIS population is an appropriate registrational approach for NDV-01. This feedback provides a clear and efficient development path toward a potential NDA submission for NDV-01 as a bladder-sparing therapeutic option in a patient population with significant unmet need.
The FDA also provided separate, supportive written feedback on the Company's planned single registrational study in intermediate-risk NMIBC in the adjuvant setting, which is expected to follow an open-label, randomized-to-observation design.
Relmada continues to anticipate initiating both registrational trials in the first half of 2026.