Relmada announces FDA alignment on two NDV-01 Phase III trial paths; 92% complete response rate at any time

RELMADA THERAPEUTICS, INC.

FDA supports single-arm registrational trial in refractory BCG-unresponsive NMIBC and randomized trial in intermediate-risk NMIBC.
No additional non-clinical studies required; 505(b)(2) NDA path confirmed by FDA.
92% overall CR rate at any time (23/25); 85% at 9 months; no Grade 3+ TRAEs or discontinuations.
Preliminary cash of $13.9M as of Sep 30, 2025 (unaudited).
Phase III programs targeted to start in H1 2026; follow-up Type B meetings requested.

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