{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-23-050940","form_type":"8-K","ticker":"SCYX","cik":"0001178253","company_name":"SCYNEXIS INC","filed_at":"2023-10-02T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.426746+00:00","generated_at":"2026-06-10T06:16:18.929861+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"SCYNEXIS recalls BREXAFEMME; FDA places clinical hold after cross-contamination risk","bullets":["Recall of BREXAFEMME (ibrexafungerp) initiated Sep 25, 2023 due to potential cross-contamination during manufacture.","FDA concurred with voluntary hold and placed clinical hold on Phase 3 MARIO and Phase 1 lactation studies.","Completed studies (FURI, CARES, VANQUISH, SCYNERGIA) unaffected; compassionate use may continue with physician benefit-risk assessment.","Pre-clinical compound SCY-247 not impacted by these developments."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-23-050940","json":"https://secwatch.observer/filing/0000950170-23-050940.json","markdown":"https://secwatch.observer/filing/0000950170-23-050940.md","text":"https://secwatch.observer/filing/0000950170-23-050940.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1178253/000095017023050940/0000950170-23-050940-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1178253/000095017023050940/scyx-20230927.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T06:16:18.929861+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"}