---
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"
generated_at: "2026-06-10T06:16:18.929861+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# SCYNEXIS recalls BREXAFEMME; FDA places clinical hold after cross-contamination risk

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-050940
- JSON: https://secwatch.observer/filing/0000950170-23-050940.json
- Plain text: https://secwatch.observer/filing/0000950170-23-050940.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.