secwatch.observer — SEC 8-K summary
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Issuer:     RELMADA THERAPEUTICS, INC. (RLMD)
CIK:        0001553643
Form:       8-K
Filed at:   2025-09-10T23:59:59+00:00
Accession:  0001213900-25-086389
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1553643/000121390025086389/0001213900-25-086389-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1553643/000121390025086389/ea0256582-8k_relmada.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-086389

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer