Relmada Therapeutics Announces Presentation of NDV-01 Phase 2 Data at the Society for Urologic Oncology

Core Insights - Relmada Therapeutics is advancing NDV-01, a sustained release intravesical formulation of gemcitabine/docetaxel, into Phase 3 studies for non-muscle invasive bladder cancer (NMIBC) in H1 2026, targeting high-risk and intermediate-risk NMIBC patients, which account for approximately 80% of new NMIBC cases annually in the U.S. [1][2][9] Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system conditions, with NDV-01 as a lead candidate [10]. Product Details - NDV-01 is designed for bladder retention and gradual drug release over 10 days, enhancing local exposure while minimizing systemic toxicity. It is a ready-to-use formulation that can be administered in-office without the need for anesthesia or specialized equipment [5]. Clinical Study Information - The ongoing Phase 2 study of NDV-01 is an open-label, single-arm trial evaluating safety and efficacy in patients with high-grade NMIBC, with primary endpoints including safety and complete response rate at 12 months [6]. Market Opportunity - NMIBC represents 75-80% of all bladder cancer cases, with a high recurrence rate of 50-80% over five years. With over 744,000 prevalent cases in the U.S. and limited treatment options, the market potential for NDV-01 is significant [9]. Upcoming Presentation - A poster highlighting the 6-month follow-up data from the Phase 2 trial will be presented at the Society of Urologic Oncology 26 Annual Meeting on December 4, 2025 [1][8].