{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-110477","form_type":"8-K","ticker":"CRMD","cik":"0001410098","company_name":"CorMedix Inc.","filed_at":"2026-10-19T12:00:28+00:00","discovered_at":"2026-10-19T12:05:00.331154+00:00","generated_at":"2026-10-19T12:05:05.495618+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"CorMedix FDA accepts REZZAYO sNDA for fungal prophylaxis with Priority Review; PDUFA set for Q1 2027","bullets":["FDA accepted for filing the sNDA, submitted by partner Mundipharma, for REZZAYO (rezafungin) prophylaxis of invasive fungal disease in adults undergoing allogeneic HSCT.","Priority Review granted with a PDUFA target action date in Q1 2027; CorMedix targets beginning promotional efforts in H2 2027.","sNDA supported by the Phase III ReSPECT pivotal study, for which CorMedix reported positive topline results in April 2026.","Rezafungin holds U.S. orphan drug exclusivity through 2035 and patent coverage through 2038; REZZAYO is already approved for candidemia and invasive candidiasis.","Company cautions acceptance and Priority Review do not assure approval; FDA could request more data, extend review, or grant narrower labeling."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-110477","json":"https://secwatch.observer/filing/0001213900-26-110477.json","markdown":"https://secwatch.observer/filing/0001213900-26-110477.md","text":"https://secwatch.observer/filing/0001213900-26-110477.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1410098/000121390026110477/0001213900-26-110477-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1410098/000121390026110477/ea0308957-8k_cormedix.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-19T12:05:05.495618+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"}