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.