Relmada outlines Phase 3 trial plans for bladder cancer drug NDV-01

Relmada Therapeutics Inc. (NASDAQ: RLMD) plans to initiate a Phase 3 registrational trial for its bladder cancer treatment NDV-01 in the first half of 2026, according to a shareholder letter released by the company.

The clinical-stage biotechnology company reported that six-month follow-up data from its Phase 2 study of NDV-01 showed a 91% complete response rate at any time point following treatment. NDV-01 is a sustained-release formulation of gemcitabine and docetaxel being developed for non-muscle invasive bladder cancer.

The company added two bladder cancer specialists to its team: Raj S. Pruthi as Chief Medical Officer–Oncology and Yair Lotan as Chair of the Clinical Advisory Board. Relmada stated that regulatory filings and manufacturing scale-up activities are underway to support the Phase 3 trial preparation.

The company also outlined plans for sepranolone, a treatment being developed for compulsivity disorders including Prader-Willi Syndrome. Relmada intends to initiate a Phase 2 study in PWS in the first half of 2026, based on proof-of-concept data in Tourette's syndrome.

Upcoming milestones for NDV-01 include nine-month Phase 2 results in the fourth quarter of 2025, twelve-month results in the first quarter of 2026, and U.S. IND clearance in the first half of 2026. For sepranolone, the company plans FDA engagement and manufacturing activities in the second half of 2025.

The information was provided in a letter to shareholders from Chief Executive Officer Sergio Traversa dated September 10, 2025.

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