CORAL GABLES, Fla., November 4, 2025 — Leads & Copy —
Relmada Therapeutics, Inc. (Nasdaq: RLMD) announced positive written feedback from the FDA regarding its planned Phase 3 program for NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients. The company will request follow-up meetings to discuss each development path.
The FDA supports two potential registrational trials: a registrational trial in 2nd line refractory BCG-unresponsive NMIBC, and a randomized controlled trial in intermediate-risk NMIBC. Feedback also confirmed no additional non-clinical studies are required. 9-month follow-up data for NDV-01 showed a 92% overall response rate at any time in NMIBC, with good overall safety.
Key outcomes from the FDA Type B pre-IND meeting include agreement that a single-arm trial might be acceptable in a more refractory patient population, and agreement that a proposal to randomize patients post-TURBT to adjuvant NDV-01 vs observation is generally acceptable.
Relmada’s Chief Medical Officer for Urology, Raj Pruthi, MD, believes the FDA’s guidance provides a path to advance NDV-01 for patients with NMIBC with limited options. Chief Executive Officer Sergio Traversa stated that NDV-01 has strong potential to transform the treatment of NMIBC and become a best-in-class therapy. Phase 3 programs are expected to begin in the first half of 2026.
Relmada also announced 9-month follow-up data from the Phase 2 study of NDV-01, showing a 92% complete response rate at any time, 84% at 3 months, 87% at 6 months, and 85% at 9 months. Two subjects reached 12-month assessment, with both having a CR. There was no progression to muscle invasive disease, no radical cystectomy, and no new safety signals.
Relmada Therapeutics is focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development.
Contact: Brian Ritchie, LifeSci Advisors, britchie@lifesciadvisors.com
Corporate Communications, media@relmada.com
Source: Relmada Therapeutics, Inc.
