---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-086389"
form_type: "8-K"
ticker: "RLMD"
cik: "0001553643"
company_name: "RELMADA THERAPEUTICS, INC."
filed_at: "2025-09-10T23:59:59+00:00"
generated_at: "2026-05-17T06:59:44.380066+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001213900-25-086389
- form_type: 8-K
- ticker: RLMD
- cik: 0001553643
- company_name: RELMADA THERAPEUTICS, INC.
- filed_at: 2025-09-10T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1553643/000121390025086389/0001213900-25-086389-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1553643/000121390025086389/ea0256582-8k_relmada.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-086389
- JSON: https://secwatch.observer/filing/0001213900-25-086389.json
- Plain text: https://secwatch.observer/filing/0001213900-25-086389.txt

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