---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-105593"
form_type: "8-K"
ticker: "RLMD"
cik: "0001553643"
company_name: "RELMADA THERAPEUTICS, INC."
filed_at: "2025-11-04T23:59:59+00:00"
generated_at: "2026-05-17T00:37:13.931501+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-25-105593
- form_type: 8-K
- ticker: RLMD
- cik: 0001553643
- company_name: RELMADA THERAPEUTICS, INC.
- filed_at: 2025-11-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1553643/000121390025105593/0001213900-25-105593-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1553643/000121390025105593/ea0263497-8k_relmada.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-105593
- JSON: https://secwatch.observer/filing/0001213900-25-105593.json
- Plain text: https://secwatch.observer/filing/0001213900-25-105593.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.