Relmada Therapeutics Reports Positive 12-Month Phase 2 Data For NDV-01 In Bladder Cancer

Relmada Therapeutics

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(RTTNews) - Relmada Therapeutics, Inc. (RLMD) on Monday announced positive 12-month interim results from its Phase 2 trial evaluating NDV-01 for high-risk non-muscle invasive bladder cancer.

The bladder cancer treatment achieved a 76 percent complete response rate at 12 months, with an 80 percent response rate among patients with BCG-unresponsive disease.

The therapy also showed a favorable safety profile, with no progression to muscle-invasive disease and no patients requiring radical cystectomy. NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel designed for simplified in-office administration.

Based on the results, Relmada plans to advance NDV-01 into the Phase 3 RESCUE registrational program, expected to begin in mid-2026, targeting both BCG-unresponsive and intermediate-risk NMIBC patient groups.

RLMD is currently trading at $5.89 up $1.44 or 32.33 percent on the Nasdaq.