Relmada Therapeutics, a clinical-stage biotechnology company developing innovative therapies for oncology and central nervous system disorders, announced the appointment of Max Kates, MD, Associate Professor of Urology and Oncology at Johns Hopkins University School of Medicine, to its Clinical Advisory Board (CAB).

Dr. Kates will support the continued development of NDV-01, Relmada’s novel sustained-release formulation of gemcitabine and docetaxel, being advanced for the potential treatment of non-muscle invasive bladder cancer (NMIBC). The Company expects to initiate the Phase 3 program for NDV-01 in the first half of 2026.

“With preparations underway for the Phase 3 NDV-01 clinical program in NMIBC, we are delighted to welcome Dr. Kates to the Relmada Clinical Advisory Board,” said Raj Pruthi, MD, Chief Medical Officer – Urology, Relmada Therapeutics. “His leadership as chair of the landmark Phase 3 BRIDGE trial and his involvement in multiple practice-changing studies provide invaluable clinical insight. Dr. Kates’ expertise will strengthen the design and execution of our Phase 3 program, helping ensure its success and real-world relevance for both clinicians and patients.”

Dr. Kates added, “As chair of the international Phase 3 BRIDGE Study, I’ve seen the growing enthusiasm among clinicians for the intravesicular delivery of gemcitabine and docetaxel as a promising bladder-sparing treatment for NMIBC. The initial safety and efficacy data for NDV-01, presented at the American Urological Association in April 2025 and updated in August, highlight the potential of this sustained-release ‘Gem/Doce’ formulation to significantly improve patient outcomes. NDV-01 could represent a major advance in the management of NMIBC, and I’m honored to join the Relmada Clinical Advisory Board to contribute my experience to its pivotal development program.”

Relmada’s NDV-01 program is designed to build upon the growing body of clinical evidence supporting the role of gemcitabine and docetaxel combination therapy in NMIBC, with the goal of delivering improved efficacy, safety, and convenience through a proprietary sustained-release formulation.