Relmada Therapeutics provided an unscheduled Form 8-K update in November 2025 detailing significant progress across its pipeline and preliminary financials.
NDV-01 (NMIBC) Regulatory and Clinical Update: The company received positive FDA feedback supporting two separate registrational Phase 3 trial paths for NDV-01 in Non-Muscle Invasive Bladder Cancer (NMIBC), utilizing existing safety data under the 505(b)(2) pathway. No further non-clinical studies are required. The registrational Phase 3 studies are slated to initiate in H1 2026. Pathway 1 allows a single-arm trial for high-grade, BCG
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