Relmada adds NDV-01 and sepranolone; NDV-01 Phase 2 shows 91% CR rate, Phase 3 planned 1H 2026

RELMADA THERAPEUTICS, INC.

Added two Phase 2 candidates: NDV-01 (NMIBC) and sepranolone (Prader-Willi Syndrome/compulsivity disorders).
NDV-01 six-month Phase 2 follow-up: 91% complete response rate at any time point.
Phase 3 registrational trial for NDV-01 targeted for 1H 2026; regulatory filings and manufacturing scale-up underway.
Sepranolone Phase 2 study in PWS planned for 1H 2026; proof-of-concept data in Tourette's support.
Appointed Dr. Raj S. Pruthi as CMO–Oncology and Dr. Yair Lotan as Chair of Clinical Advisory Board.

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