{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-22-078255","form_type":"8-K","ticker":"RLMD","cik":"0001553643","company_name":"RELMADA THERAPEUTICS, INC.","filed_at":"2022-12-07T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.124281+00:00","generated_at":"2026-06-21T08:07:32.304414+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Relmada phase 3 RELIANCE I trial for REL-1017 fails primary endpoint; post-hoc analysis shows significance","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-22-078255","json":"https://secwatch.observer/filing/0001213900-22-078255.json","markdown":"https://secwatch.observer/filing/0001213900-22-078255.md","text":"https://secwatch.observer/filing/0001213900-22-078255.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1553643/000121390022078255/0001213900-22-078255-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1553643/000121390022078255/ea169812-8k_relmada.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T08:07:32.304414+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}