Relmada Therapeutics, Inc. (RLMD) shares are up 43% in pre-market following the announcement of 12-month interim Phase 2 data for NDV-01 in non-muscle invasive bladder cancer and an oversubscribed $160 million private placement financing.
Non-muscle invasive bladder cancer (NMIBC) is an early-stage bladder cancer that has not spread into the muscle wall. Patients often face high recurrence rates and limited treatment options, particularly those who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy.
NDV-01, Relmada's lead candidate in the Phase 2 study, showed encouraging durability of response at the 12-month mark, supporting the drug's potential as a novel therapy for patients with bladder cancer who often face limited treatment options. Relmada said the interim results reinforce earlier findings and provide a strong basis for continued clinical development.
Taken together, these findings support the potential best-in-class profile of NDV-01 and advancement into the Phase 3 RESCUE registrational program.
Phase 3 RESCUE Registrational Pathways:-Pathway 1: An open label randomized trial in intermediate-risk NMIBC (NDV-01 vs. observation) following TURBT. Primary endpoint: Disease-free survival, key secondary endpoints include high-grade recurrence free survival, progression free survival, quality of life metrics.
-Pathway 2: A single-arm trial in second line (2L) BCG-unresponsive NMIBC with carcinoma in situ patients. Primary endpoint: Complete response (CR) rate; key secondary endpoints include duration of response, progression-free survival, and recurrence-free survival among responders.
Relmada expects U.S. IND clearance and initiation of the RESCUE program by mid-2026, with initial 3-month results from Phase 3 2L BCG-unresponsive study anticipated by year-end 2026.
In parallel, the company announced it has successfully raised $160 million in an oversubscribed private placement, with participation from leading healthcare investors. Relmada noted that the financing will extend its cash runway and support ongoing clinical programs, including further evaluation of NDV-01.
Together, the clinical progress and strengthened balance sheet highlight Relmada's momentum as it advances its pipeline.
RLMD has traded between $0.24 and $5.12 over the past year. The stock closed Friday's (March 6, 2026) trading at $4.45, up 0.45%. In the pre-market the stock is at $6.39, up 45%, touching a new 52-week high.
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