Relmada Therapeutics (RLMD)

Executive Summary

Relmada Therapeutics is a clinical-stage biotechnology company developing innovative therapies for central nervous system (CNS) disorders and oncology. Its lead candidate, REL-1017, is an oral NMDA receptor antagonist being investigated for major depressive disorder (MDD). Although two Phase 3 trials (NCT05081167 and NCT04688164) have been completed, results have not yet led to regulatory submission, and an additional Phase 3 trial (NCT04855760) was completed in 2023. The company is also advancing NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer (NMIBC), which recently initiated a Phase 3 registrational trial (NCT07464145) in June 2026. With a strong focus on differentiated mechanisms, Relmada aims to address high unmet needs in depression and bladder cancer, though past trial outcomes remain a key uncertainty.

Upcoming Catalysts (preview)

• Q4 2026REL-1017 Phase 3 data readout for MDD40% success
• Q3 2026NDV-01 Phase 3 trial (NCT07464145) enrollment update70% success
• Q4 2026Potential FDA feedback or end-of-Phase 2 meeting for NDV-0160% success