other material
confidence high
sentiment negative
materiality 0.90
SCYNEXIS recalls BREXAFEMME and pauses Phase 3 MARIO study on cross-contamination risk
SCYNEXIS INC
- GSK review found a beta-lactam drug manufactured on equipment shared with ibrexafungerp; potential cross-contamination risk.
- No known contamination of ibrexafungerp and no adverse events reported; recall is out of caution.
- Market recall of BREXAFEMME (ibrexafungerp tablets) and temporary hold on all clinical studies, including Phase 3 MARIO.
- Mitigation strategy and resupply plan to be determined; ongoing collaboration with GSK.