Aprea Therapeutics Stock Drops On FDA Clinical Hold On Eprenetapopt Myeloid Malignancy Trials

  • The FDA has instituted a partial clinical hold on Aprea Therapeutics Inc's APRE clinical trials of eprenetapopt (APR-246) combined with azacitidine in its myeloid malignancy programs. 
  • Approximately 20 patients currently receiving eprenetapopt in combination with azacitidine in the Company's myeloid malignancy programs, including the MDS, AML, and post-transplant maintenance trials, all of which have completed enrollment. 
  • Patients who are benefiting from treatment can continue to receive study treatment. As part of the clinical hold, no additional patients can be enrolled in these trials.
  • Aprea intends to work closely with the FDA to analyze the data, address the specific questions raised, and seek to resolve the partial clinical hold as soon as possible.
  • The Company will host a webcast conference call today at 8:30 AM E.T. 
  • Price Action: APRE shares are down 8.14% at $3.95 during the premarket session on the last check Friday.
  • Related content: Benzinga's Full FDA Calendar.
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