Relmada Therapeutics Appoints Distinguished Urologic Oncologist, Max Kates, MD, to the Clinical Advisory Board to Support Development of NDV-01

Core Viewpoint - Relmada Therapeutics has appointed Dr. Max Kates to its Clinical Advisory Board to support the development of NDV-01 for non-muscle invasive bladder cancer (NMIBC), with the Phase 3 program expected to begin in the first half of 2026 [2][3]. Company Overview - Relmada Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapies for oncology and central nervous system conditions [11]. - The company's lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development [11]. NDV-01 Development - NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel, designed for the treatment of NMIBC, allowing for gradual drug release over 10 days [8][9]. - The formulation aims to enhance local exposure while minimizing systemic toxicity and is convenient to administer in-office [9]. - NDV-01 has the potential to serve as a frontline or salvage therapy for NMIBC, which represents 75-80% of all bladder cancer cases [10]. Market Opportunity - NMIBC is associated with a high recurrence rate of 50-80% over five years, with over 744,000 prevalent cases in the U.S., indicating a significant market opportunity for NDV-01 [10]. Dr. Max Kates' Role - Dr. Kates brings extensive experience from chairing the Phase 3 BRIDGE trial and has a strong background in urologic oncology, which will be beneficial for the design and conduct of the NDV-01 Phase 3 program [3][5]. - His expertise includes advancements in surgical innovation and novel therapies for bladder cancer, which will contribute to the real-world applicability of NDV-01 [3][5].