Relmada Therapeutics presents initial Phase 2 NDV-01 data at AUA2025

Relmada Therapeutics (RLMD) announced that “positive” initial data from the Phase 2 study of NDV-01 showed that 90% of patients achieved high-grade disease-free status at any time point following treatment, demonstrating strong clinical activity and supporting further development of NDV-01 for the treatment of non-muscle invasive bladder cancer. The data were presented today at the American Urology Association 2025 Annual Meeting with a data cutoff date of April 20, the company noted. “We believe NDV-01 has the potential to become the class-leading therapy for NMIBC across a wide spectrum of patients. The data presented at AUA2025 provide compelling proof-of-concept for NDV-01 as a bladder-sparing therapy. With its strong responses and tolerability combined with an administration time of less than 10 minutes, NDV-01 represents a potentially significant advance in outpatient bladder cancer treatment. We are enthusiastic about advancing this differentiated, ready-to-use GEM/DOCE formulation to improve patient outcomes and expand treatment options in NMIBC,” said Sergio Traversa, CEO of Relmada.