{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-25-105593","form_type":"8-K","ticker":"RLMD","cik":"0001553643","company_name":"RELMADA THERAPEUTICS, INC.","filed_at":"2025-11-04T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.721218+00:00","generated_at":"2026-05-17T00:37:13.931501+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Relmada announces FDA alignment on two NDV-01 Phase III trial paths; 92% complete response rate at any time","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-25-105593","json":"https://secwatch.observer/filing/0001213900-25-105593.json","markdown":"https://secwatch.observer/filing/0001213900-25-105593.md","text":"https://secwatch.observer/filing/0001213900-25-105593.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1553643/000121390025105593/0001213900-25-105593-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1553643/000121390025105593/ea0263497-8k_relmada.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T00:37:13.931501+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"}