Relmada Therapeutics presented the 6‑month follow‑up data from its Phase 2 study of NDV‑01, a sustained‑release intravesical gemcitabine/docetaxel formulation, at the Society of Urologic Oncology (SUO) 26th Annual Meeting in Phoenix, Arizona. The poster, delivered at 2:30 PM Mountain Time, was presented by Dr. Yair Lotan, Chairman of Relmada’s Clinical Advisory Board.
The data build on the company’s earlier 9‑month results, which reported a 92 % complete‑response rate in high‑grade non‑muscle‑invasive bladder cancer patients. The 6‑month analysis confirms the durability of the response and provides the first peer‑reviewed evidence of NDV‑01’s safety and efficacy in a larger cohort, strengthening the case for a bladder‑sparing treatment option.
Relmada’s CEO, Sergio Traversa, emphasized that the results “de‑risk the lead program and establish a strong foundation for future success.” He noted that the FDA has aligned on two registrational pathways for NDV‑01, one for high‑grade, BCG‑unresponsive patients and another for intermediate‑risk patients, positioning the company to pursue a broad market reach.
The company plans to initiate Phase 3 studies in the first half of 2026, supported by a $100 million financing round that extends its cash runway to 2028. The funding allows Relmada to accelerate clinical development while maintaining a disciplined cost structure, a strategy that has already reduced R&D and G&A expenses in the most recent quarter.
Investors responded positively to the announcement, reflecting confidence in the clinical data and the company’s strategic trajectory. The presentation underscores Relmada’s potential to transform the treatment landscape for NMIBC, offering a less invasive alternative that could reduce recurrence rates and improve patient quality of life.
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