Foghorn : FDA Lifts Clinical Hold On Phase 1 Study Of FHD-286 In Relapsed And/or Refractory AML/MDS

(RTTNews) - The U.S. Food and Drug Administration has lifted the clinical hold on the Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia or AML and myelodysplastic syndrome or MDS, Foghorn Therapeutics Inc. (FHTX) said in a statement on Monday.

In Monday pre-market trade, FHTX was trading at $8.40 up $1.30 or 18.31%.

In August, 2022, Foghorn announced a full clinical hold in the AML/MDS Phase 1 study due to suspected cases of fatal differentiation syndrome believed to be associated with FHD-286 treatment.

The clinical hold was lifted as of June 1, 2023. Foghorn plans to commence a Phase 1 study of FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory AML patients in the third quarter of 2023.

The decision to advance to the Phase 1 combination study is based on clinical data demonstrating FHD-286's effect as a broad-based differentiation agent, its safety profile, as well as supportive pre-clinical combination data, including robust efficacy data in multiple CDX and PDX models, the company said.

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