Aprea Therapeutics Stock Drops After FDA Clinical Hold On Another Blood Cancer Study

  • After instituting a partial clinical hold on Aprea Therapeutics Inc's APRE myeloid malignancies program, the FDA has placed a clinical hold on Aprea's lymphoid malignancy study. 
  • The trial is evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies.
  • The agency's concerns referred to the safety and efficacy data from the Phase 3 myelodysplastic syndromes (MDS) clinical trial. 
  • One chronic lymphocytic leukemia (CLL) patient is currently on study treatment receiving eprenetapopt / venetoclax / rituximab combo and has achieved complete remission (CR). 
  • No additional patients can be enrolled until the clinical hold is resolved.
  • Price Action: APRE shares are down 12.20% at $3.60 during the premarket session on the last check Thursday.
  • Related content: Benzinga's Full FDA Calendar.
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