FDA Lifts Clinical Hold On Aprea's Eprenetapopt Trial In Lymphoid Malignancies

  • The FDA removed the full clinical hold on Aprea Therapeutics Inc's APRE trial evaluating the combination of eprenetapopt, with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies.
  • The agency issued a clinical hold on the study in August
  • The agency's concerns referred to the safety and efficacy data from the Phase 3 myelodysplastic syndromes (MDS) clinical trial. 
  • A pivotal Phase 3 trial of eprenetapopt and azacitidine for the frontline treatment of TP53 mutant MDS has been completed. The trial failed to meet the primary statistical endpoint of complete remission. 
  • Eprenetapopt is currently on clinical hold in myeloid malignancies.
  • Price Action: APRE shares are down 0.48% at $4.10 during the market session on the last check Thursday.
  • Editor's Note: The story has been corrected to include 'Lymphoid Malignancies' in the headline.
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