FDA puts partial hold on Foghorn's Phase I study of FHD-286
US cancer-focused biotech Foghorn Therapeutics (Nasdaq: FHTX) yesterday announced the Food and Drug Administration (FDA) has placed the Phase I dose escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) on a partial clinical hold.
The news saw the company’s share down more than 20% at $9.09 in pre-market activity this morning.
The partial clinical hold was initiated by the FDA 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. The FDA has requested a review of the safety database, risk mitigation strategies and a breakdown of clinical activity across dose levels.
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