Foghorn’s AML/MDS Program Likely Still A Go Despite Partial Hold

The company’s Phase I study of FHD-286 had a patient death due to differentiation syndrome, but that’s a known adverse event in multiple approved AML drugs.

Foghorn announced a partial clinical hold on its Phase I AML/MDS study following a patient death • Source: Shutterstock

Foghorn Therapeutics Inc.’s development program for FHD-286 has run into trouble as the US Food and Drug Administration has placed a partial clinical hold in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) following a patient death. But the drug may still be able to move forward as the death was due to a problem that has occurred with some approved AML drugs.

The company said 19 May that the FDA had placed the partial clinical hold on its dose-escalation study of FHD-286...

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