- 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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