Relmada Therapeutics To Present NDV-01 Data at AUA2025

Core Viewpoint - Relmada Therapeutics is advancing its investigational therapy NDV-01 for high-grade non-muscle invasive bladder cancer (HG-NMIBC), with a presentation scheduled at the American Urology Association conference in April 2025 [1][2]. Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for targeted patient populations [7]. Product Details - NDV-01 is a sustained-release formulation combining gemcitabine and docetaxel, designed for intravesical administration without the need for anesthesia or specialized equipment [2][3]. - The formulation aims to maximize local drug concentration and prolong exposure while minimizing systemic toxicity, with a gradual release over a 10-day period [3]. - NDV-01 has the potential to be a first-line therapy for HG-NMIBC and may also be applicable for patients who have failed other treatments, including BCG immunotherapy [3][6]. Market Opportunity - The U.S. market for non-muscle invasive bladder cancer (NMIBC) is estimated to be a multi-billion dollar opportunity, driven by the increasing incidence of bladder cancer and the demand for effective therapies like NDV-01 [6]. - NMIBC has a high recurrence rate of 50-75% over seven years, indicating a significant need for effective treatment options [5][6]. - The global market is expected to grow due to limited approved treatment options and the high demand for minimally invasive therapies [6]. Clinical Development - NDV-01 is currently being evaluated in a Phase 2 study, with results expected to support further development [8].