{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-22-046610","form_type":"8-K","ticker":"CRMD","cik":"0001410098","company_name":"CorMedix Inc.","filed_at":"2022-08-11T23:59:59+00:00","discovered_at":"2026-05-14T18:03:55.653901+00:00","generated_at":"2026-06-24T00:43:57.652528+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"CorMedix receives second FDA CRL for DefenCath; Q2 net loss $7.6M","bullets":["Second CRL from FDA for DefenCath NDA due to unresolved deficiencies at CMO and heparin supplier.","Entered agreement with Alcami as alternative manufacturer; expects to submit NDA supplement around Q1 2023.","CMS granted conditional NTAP reimbursement, conditioned on FDA approval before July 1, 2023.","Net loss Q2 2022: $7.6M ($0.19/share) vs $4.6M ($0.12/share) in Q2 2021; OpEx $8.3M, up 41%.","Cash and short-term investments $64.6M at June 30, 2022; funding through at least Q3 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-22-046610","json":"https://secwatch.observer/filing/0001213900-22-046610.json","markdown":"https://secwatch.observer/filing/0001213900-22-046610.md","text":"https://secwatch.observer/filing/0001213900-22-046610.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1410098/000121390022046610/0001213900-22-046610-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1410098/000121390022046610/ea164139-8k_cormedixinc.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-24T00:43:57.652528+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"}