secwatch.observer — SEC 8-K summary
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Issuer:     SCYNEXIS INC (SCYX)
CIK:        0001178253
Form:       8-K
Filed at:   2023-09-25T23:59:59+00:00
Accession:  0000950170-23-049544
Event type: other_material
Sentiment:  negative
Materiality: 0.90
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

SCYNEXIS recalls BREXAFEMME and pauses Phase 3 MARIO study on cross-contamination risk
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1178253/000095017023049544/0000950170-23-049544-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1178253/000095017023049544/scyx-20230919.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-049544

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