Aprea Therapeutics: FDA Puts Clinical Hold on Lymphoid Malignancy Program
12 August 2021 - 8:41PM
Dow Jones News
By Colin Kellaher
Aprea Therapeutics Inc. on Thursday said the U.S. Food and Drug
Administration has placed a clinical hold on its clinical trial
evaluating eprenetapopt with acalabrutinib or with venetoclax and
rituximab in lymphoid malignancies.
The Boston biopharmaceutical company said the agency's concerns
relate to the safety and efficacy data from a Phase 3 study in
myelodysplastic syndromes.
Aprea said it can't enroll any additional patients in the study
until the hold is resolved, though current patients who are
deriving clinical benefit can continue to receive study
treatment.
The news comes a week after Aprea said the FDA had placed a
partial clinical hold on its studies of eprenetapopt in combination
with azacitidine in its myeloid malignancy programs.
Aprea said it plans to work closely with the FDA to address the
agency's questions, adding that it aims to resolve the clinical
hold as soon as possible.
Shares of Aprea, which closed Wednesday at $4.10, fell nearly
10% in premarket trading Thursday.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
August 12, 2021 06:34 ET (10:34 GMT)
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