FDA Clears Curis' Lymphoma Study, Keeping Leukemia Trial Still Stalled

  • The FDA has lifted the partial clinical hold on Curis Inc's CRIS TakeAim Lymphoma Phase 1/2 study of emavusertib after reviewing the comprehensive data package submitted by the company.
  • "We are working with our clinical sites to quickly resume enrollment of new patients in this study in the third quarter," said James Dentzer, President and CEO of Curis.
  • Previously, Curis announced that the FDA had placed separate partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies in April.
  • Related Content: After Leukemia Trial, FDA Puts Partial Hold On Curis' Lymphoma Study.
  • The clinical hold study was lifted following an agreement with the FDA on Curis's strategy for rhabdomyolysis identification and management and on enrolling at least nine additional patients at the 200 mg dose level of emavusertib in combination with ibrutinib.
  • With the partial clinical hold lifted on the TakeAim Lymphoma study, the company is updating its timeline for clinical data release to reflect the availability of updated preliminary data from this study in 2023. 
  • In addition, Curis is discussing the plans for emavusertib, including alignment on optimal dose and development path.
  • Price Action: CRIS shares are up 29.50% at $1.36 during the premarket session on the last check Thursday.
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