secwatch.observer — SEC 8-K summary
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Issuer:     SCYNEXIS INC (SCYX)
CIK:        0001178253
Form:       8-K
Filed at:   2023-10-02T23:59:59+00:00
Accession:  0000950170-23-050940
Event type: other_material
Sentiment:  negative
Materiality: 0.90
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1178253/000095017023050940/0000950170-23-050940-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1178253/000095017023050940/scyx-20230927.htm
  HTML page:      https://secwatch.observer/filing/0000950170-23-050940

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer