other material
confidence high
sentiment negative
materiality 0.90
SCYNEXIS recalls BREXAFEMME; FDA places clinical hold after cross-contamination risk
SCYNEXIS INC
- 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.