Relmada Therapeutics announces FDA feedback on study paths for NDV-01

Relmada Therapeutics (RLMD) announced the receipt of written minutes from a Type B pre-IND meeting with the U.S. Food and Drug Administration, FDA, regarding the planned Phase 3 program for NDV-01 in non-muscle invasive bladder cancer, NMBIC, patients. The Company will be requesting follow-up meetings with FDA to discuss each development path. Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDV-01, expected to begin in H1 2026 and incorporating two independent studies for approval in two separate indications. Sergio Traversa, Chief Executive Officer of Relmada Therapeutics, stated: “We added NDV-01 to our portfolio based on its strong potential to transform the treatment of NMIBC. The outcome of our Type B meeting with the FDA further reinforces our confidence in the path forward and in NDV-01’s potential to become a best-in-class, durable, ready and easy-to-use, in-office, bladder-sparing therapy. We look forward to initiating the Phase 3 programs in the first half of 2026.”