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Relmada Therapeutics advances NDV-01 into Phase 3 studies for NMIBC.
ByAinvest
Wednesday, Dec 3, 2025 7:35 am ET1min read
Relmada Therapeutics announced 6-month follow-up data from its ongoing Phase 2 trial of NDV-01, an intravesical formulation of gemcitabine/docetaxel, for non-muscle invasive bladder cancer. The data showed favorable overall safety. The company plans to advance NDV-01 into Phase 3 studies in two indications, high-risk NMIBC and intermediate-risk NMIBC, in H1 2026. These indications represent about 80% of new NMIBC cases in the US, or around 54,000 people.
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