Relmada Therapeutics Receives FDA Feedback on NDV-01
Relmada Therapeutics announced that it has received written feedback from the U.S. Food and Drug Administration, FDA, regarding the registrational development pathway for NDV-01 in 2nd-line refractory, high-grade BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ and in intermediate risk NMIBC in the adjuvant setting, where there are currently no approved therapies. 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.
