Aprea Therapeutics : FDA Lifts Hold on Eprenetapopt Study in Lymphoid Malignancies

By Colin Kellaher

Aprea Therapeutics Inc. on Thursday said the U.S. Food and Drug Administration has lifted the clinical hold on a study of its lead compound eprenetapopt in lymphoid malignancies.

The Boston biopharmaceutical company in August said the agency placed the hold on the study of eprenetapopt with acalabrutinib or with venetoclax and rituximab due to concerns related to the safety and efficacy data from a Phase 3 study in myelodysplastic syndromes.

Aprea said it has addressed the FDA's concerns and received clearance to proceed with a future clinical study of eprenetapopt in non-Hodgkin's lymphomas.

Shares of Aprea, which closed Wednesday at $4.12, rose nearly 10% in premarket trading Thursday.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

12-09-21 0835ET