FDA Places Clinical Hold On Foghorn Therapeutics' Early-Stage Blood Cancer Trial

  • The FDA has instituted a clinical hold on Foghorn Therapeutics Inc's FHTX Phase 1 dose-escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS). 
  • The FDA initiated the partial clinical hold following the report of a recent death that occurred in a subject with potential differentiation syndrome. 
  • Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that is believed to be on-target for the proposed mechanism of action for FHD-286. 
  • Also See: Foghorn Therapeutics Stock Surges After $1.5B Cancer Pact With Eli Lilly.
  • The FDA has requested a review of the safety database, risk mitigation strategies, and clinical activity breakdown across dose levels.
  • Patients currently enrolled in the dose-escalation Phase 1 study of FHD-286 in AML/MDS and benefitting from treatment may continue to receive treatment. However, no new patients can be enrolled. 
  • The partial hold does not apply to the FHD-286 dose-escalation Phase 1 study in metastatic uveal melanoma.
  • Until Foghorn has resolved the partial clinical hold for the AML/MDS study, the company is suspending guidance on the timing of the data release for the dose-escalation phase of the FHD-286 program.
  • Price Action: FHTX shares closed 24.9% lower at $8.60 during after-hours trading on Thursday.
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