secwatch.observer — SEC 8-K summary
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Issuer:     RELMADA THERAPEUTICS, INC. (RLMD)
CIK:        0001553643
Form:       8-K
Filed at:   2023-09-20T23:59:59+00:00
Accession:  0001213900-23-078049
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Relmada reports Phase 3 open-label data for REL-1017 in MDD: rapid, sustained symptom improvement
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- In 204 de novo patients, mean MADRS total score improved 11.3 points at Day 7 and 22.5 points at Month 12.
- Clinical response (≥50% MADRS improvement) achieved by 26.6% at Day 7 and 77.2% at Month 12.
- Remission (MADRS ≤10) rates were 12.1% at Day 7 and 54.4% at Month 12.
- Safety: ~3% discontinuation due to AEs; no new safety signals; common AEs were headache (4.4%), nausea (4.0%), dizziness (2.4%).
- Functional impairment (SDS) improved ~50% by Month 6 in de novo patients.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1553643/000121390023078049/0001213900-23-078049-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1553643/000121390023078049/ea185487-8k_relmada.htm
  HTML page:      https://secwatch.observer/filing/0001213900-23-078049

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