secwatch.observer — SEC 8-K summary
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Issuer:     RELMADA THERAPEUTICS, INC. (RLMD)
CIK:        0001553643
Form:       8-K
Filed at:   2022-12-07T23:59:59+00:00
Accession:  0001213900-22-078255
Event type: other_material
Sentiment:  negative
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Relmada phase 3 RELIANCE I trial for REL-1017 fails primary endpoint; post-hoc analysis shows significance
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- RELIANCE I did not achieve statistical significance on MADRS at Day 28: REL-1017 -15.1 vs placebo -12.9 (2.2-point difference).
- Response rate statistically significant: 39.8% REL-1017 vs 27.2% placebo (p<0.05).
- Post-hoc analysis excluding two high-enrolling centers with implausible placebo response showed 4.1-point MADRS difference (p=0.02).
- Safety profile favorable: no opioid-like, withdrawal, or psychotomimetic effects; no QTcF prolongation.
- Company is applying protocol and operational changes to the ongoing RELIANCE II trial.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1553643/000121390022078255/0001213900-22-078255-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1553643/000121390022078255/ea169812-8k_relmada.htm
  HTML page:      https://secwatch.observer/filing/0001213900-22-078255

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