Relmada Therapeutics Appoints Distinguished Urologic Oncologist, Max Kates, MD, to the Clinical Advisory Board to Support Development of NDV-01
Relmada Therapeutics (Nasdaq: RLMD) appointed Max Kates, MD, Associate Professor of Urology and Oncology at Johns Hopkins, to its Clinical Advisory Board to support development of NDV-01 for non‑muscle invasive bladder cancer. Relmada plans to initiate the Phase 3 NDV-01 program in H1 2026. Management cited Dr. Kates’ experience chairing the Phase 3 BRIDGE trial and high‑volume urologic practice insights as valuable to trial design and real‑world applicability. The company noted that initial safety and efficacy data for NDV-01 were presented at the American Urologic Association in April 2025 and updated in August 2025.
Relmada Therapeutics (Nasdaq: RLMD) ha nominato Max Kates, MD, professore associato di Urologia e Oncologia presso Johns Hopkins, nel proprio Clinical Advisory Board per supportare lo sviluppo di NDV-01 per il cancro alla vescica non a cellule muscolari invasivo. Relmada prevede di avviare lo studio di fase 3 NDV-01 nel primo semestre del 2026. La direzione ha citato l’esperienza del Dr. Kates nel presiedere lo studio di fase 3 BRIDGE e gli insight ottenuti dalla pratica urologica ad alto volume come preziosi per la progettazione dello studio e l’applicabilità nel mondo reale. L’azienda ha osservato che i dati iniziali di sicurezza ed efficacia di NDV-01 sono stati presentati all’American Urological Association nell’aprile 2025 e aggiornati nell’agosto 2025.
Relmada Therapeutics (Nasdaq: RLMD) ha nombrado a Max Kates, MD, Profesor Asociado de Urología y Oncología en Johns Hopkins, para su Junta Asesora Clínica con el fin de apoyar el desarrollo de NDV-01 para el cáncer de vejiga no músculo-invasivo. Relmada planea iniciar el programa de NDV-01 en la Fase 3 en el primer semestre de 2026. La dirección señaló que la experiencia del Dr. Kates al presidir el ensayo de Fase 3 BRIDGE y sus perspectivas de la práctica urológica de alto volumen son valiosas para el diseño de ensayos y la aplicabilidad en el mundo real. La empresa indicó que los datos iniciales de seguridad y eficacia de NDV-01 se presentaron en la American Urological Association en abril de 2025 y se actualizaron en agosto de 2025.
Relmada Therapeutics(Nasdaq: RLMD)가 존스 홉킨스 대학의 요로학 및 종양학 부교수인 Max Kates 박사(MD)를 임상 자문위원회에 임명하여 비근육침습성 방광암을 위한 NDV-01 개발을 지원합니다. Relmada는 2026년 상반기에 NDV-01의 3상 프로그램을 시작할 계획입니다. 경영진은 Dr. Kates의 3상 BRIDGE 시험 주재 경험과 고용량 비뇨의학 임상에서 얻은 인사이트가 시험 설계와 실세계 적용에 유용하다고 언급했습니다. 회사는 NDV-01의 초기 안전성 및 효능 데이터가 2025년 4월 미국 비뇨의학회에서 발표되었고 2025년 8월에 업데이트되었다고 밝혔습니다.
Relmada Therapeutics (Nasdaq : RLMD) a nommé le Dr Max Kates, MD, Professeur associé d’Urologie et d’Oncologie à Johns Hopkins, au sein de son Conseil Consultatif Clinique pour soutenir le développement de NDV-01 pour le cancer de la vessie non musculaire invasif. Relmada prévoit de lancer le programme de NDV-01 de phase 3 au cours du premier semestre 2026. La direction a cité l’expérience du Dr Kates à présider l’essai de phase 3 BRIDGE et les insights issus d’une pratique urologique à haut volume comme précieux pour la conception des essais et l’applicabilité dans le monde réel. La société a noté que les données initiales de sécurité et d’efficacité de NDV-01 ont été présentées lors de l’Association américaine d’urologie en avril 2025 et mises à jour en août 2025.
Relmada Therapeutics (Nasdaq: RLMD) hat Max Kates, MD, Professor of Urologie und Onkologie an der Johns Hopkins University, in sein Clinical Advisory Board berufen, um die Entwicklung von NDV-01 für nicht-muskelinvasiven Blasenkrebs zu unterstützen. Relmada plant, das NDV-01-Programm der Phase 3 im ersten Halbjahr 2026 zu starten. Die Geschäftsführung verwies auf die Erfahrung von Dr. Kates, die Phase-3-BRIDGE-Studie zu leiten, und auf Einblicke aus der Praxis der Hochvolumen-Urologie, die für das Studiendesign und die praktische Anwendbarkeit wertvoll sind. Das Unternehmen merkte an, dass erste Sicherheits- und Wirksamkeitsdaten von NDV-01 im April 2025 auf der American Urological Association vorgestellt und im August 2025 aktualisiert wurden.
عينت Relmada Therapeutics (بورصة ناسداك: RLMD) الدكتور ماكس كيتس، MD، أستاذ مساعد في جراحة المسالك البولية والسرطان في جونز هوبكنز، في مجلسها الاستشاري السريري لدعم تطوير NDV-01 لسرطان المثانة غير العضلي الغازي. تخطط Relmada لبدء برنامج NDV-01 في المرحلة 3 في النصف الأول من 2026. أشارت الإدارة إلى أن خبرة الدكتور كيتس في رئاسة تجربة BRIDGE في المرحلة 3 ورؤى ممارسته البولية ذات الحجم العالي ستكون ذات قيمة في تصميم التجربة وتطبيقها في العالم الواقعي. أشارت الشركة إلى أن بيانات السلامة والفعالية الأولية لـ NDV-01 تم تقديمها في جمعية المسالك البولية الأمريكية في أبريل 2025 وتحديثها في أغسطس 2025.
Relmada Therapeutics（纳斯达克：RLMD）任命Max Kates，MD，约翰霍普金斯大学泌尿学与肿瘤学副教授，加入其临床咨询委员会，以支持NDV-01在非肌层浸润性膀胱癌的开发。Relmada计划在2026年上半年启动NDV-01的3期项目。管理层表示，Kates博士主持3期BRIDGE试验的经验及其在高量级泌尿科实践中的见解对于试验设计和在真实世界中的适用性具有价值。公司指出，NDV-01的初步安全性和有效性数据已于2025年4月在美国泌尿学会会议上公布，并在2025年8月更新。
- Phase 3 NDV-01 program planned for H1 2026
- Initial NDV-01 safety and efficacy data presented Apr 2025
- Appointed Max Kates, MD to Clinical Advisory Board
- None.
Dr. Kates’ experience as chair of the landmark Phase 3 BRIDGE bladder cancer trial and dedication to patient care will be invaluable to the NDV-01 Phase 3 program
Phase 3 program for NDV-01 expected to begin in H1 2026
CORAL GABLES, Fla., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, today announced the appointment of Max Kates, MD, Associate Professor of Urology and Oncology at Johns Hopkins University School of Medicine, to Relmada’s Clinical Advisory Board (CAB) to support the development of NDV-01 for the potential treatment of non-muscle invasive bladder cancer (NMIBC). Relmada intends to initiate the Phase 3 program for NDV-01 in H1 2026.
“With preparations actively underway for the Phase 3 NDV-01 clinical program in NMIBC, we are very pleased to welcome Dr. Kates to the Relmada Clinical Advisory Board. We believe that Max’s experience chairing the landmark Phase 3 BRIDGE trial and leading several other practice-changing studies gives him a unique clinical perspective that will be invaluable to the design and conduct of the Phase 3 program,” said Raj Pruthi, MD, Chief Medical Officer-Urology, Relmada. “In addition, Max’s first-hand knowledge of the operational complexities inherent to a high-volume urologic oncology practice will help us to strengthen the Phase 3 program for NDV-01 and ensure its real-world applicability.”
“As the chair of the international Phase 3 Bridge Study, I have gained a deep appreciation for the clinical community’s optimism for the intravesicular delivery of gemcitabine and docetaxel as a potential bladder sparing treatment for NMIBC,” said Dr. Kates. “The initial safety and efficacy data for NDV-01, presented at the American Urologic Association in April, 2025, and updated in August, underscore the significant benefit that a sustained release formulation of “Gem/Doce” could offer urologic oncology practices and bladder cancer patients. I believe NDV-01 has the potential to transform the treatment of NMIBC and I am pleased to join the Relmada Clinical Advisory Board and eager to contribute my expertise to the pivotal program.”
About Max Kates, MD
Dr. Kates is a nationally recognized clinician-scientist in bladder cancer with one of the largest surgical bladder cancer practices in the U.S., integrating clinical care with translational research.
Dr. Kates serves as chair of the Phase 3 EA8212 BRIDGE Trial (NCT05538663) trial, comparing Gemcitabine/Docetaxel to BCG (Bacillus Calmette-Guérin) in non–muscle invasive bladder cancer (over 900 patients enrolled across >65 centers). He has also been the Principal Investigator on numerous studies evaluating new potential treatments for NMIBC. Dr. Kates has pioneered improvements in surgical innovation for robotic intracorporeal cystectomy and neobladder as well as novel techniques and early recovery programs for TURBT translational research, has advanced understanding of immune resistance in BCG-unresponsive disease, pioneered novel intravesical therapies, and explored antibody–drug conjugates and immunotherapy for bladder preservation.
Throughout his career, Dr. Kates has published more than 150 peer-reviewed manuscripts in leading journals such as Clinical Cancer Research, Cancer Immunology Research, Journal of Urology, and European Urology. Dr. Kates also serves as a reviewer for prominent journals including the New England Journal of Medicine, and the Journal of Clinical Oncology.
Dr. Kates is the R. Christian B. Evensen Professor of Urology and Director of the Division of Urologic Oncology at Johns Hopkins Hospital, and Associate Professor, Urology and Oncology and Co-Director of the Greenberg Bladder Cancer Institute. He received his medical degree from Mount Sinai School of Medicine in New York. He trained in general surgery and urologic surgery at John Hopkins Hospital in Baltimore, Maryland and completed a Clinical Research Fellowship at Columbia University College of Physicians and Surgeons in New York. Dr. Kates graduated with High Distinction with a B.A. from Wesleyan University.
About NDV-01
NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local exposure while minimizing systemic toxicity. NDV-01 is convenient to administer in-office, in less than 10 minutes, and does not require anesthesia or specialized equipment. It is protected by patents through 2038.
About NMIBC
NMIBC represents 75
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology-related and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs.
For more information, visit www.relmada.com
Forward-Looking Statements:
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the potential for Relmada’s product candidates to progress, including the potential for Phase 2 NDV-01 data to continue to deliver positive results supporting further development, potential for clinical trials to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to secure FDA agreement on the regulatory path for NDV-01, and sepranolone, or that future NDV-01, or sepranolone, clinical results will be acceptable to the FDA, failure to secure adequate NDV-01, or sepranolone, drug supply, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be a complete list.
Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Inquiries:
Corporate Communications
media@relmada.com
FAQ
What did Relmada announce about NDV-01 and the Phase 3 timeline for RLMD?
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Does the announcement change NDV-01 regulatory status for RLMD?
