secwatch.observer — SEC 8-K summary
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Issuer:     RELMADA THERAPEUTICS, INC. (RLMD)
CIK:        0001553643
Form:       8-K
Filed at:   2025-11-04T23:59:59+00:00
Accession:  0001213900-25-105593
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1553643/000121390025105593/0001213900-25-105593-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1553643/000121390025105593/ea0263497-8k_relmada.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-105593

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