Foghorn Therapeutics Shares Rally Premarket as FDA Lifts Clinical Hold

By Colin Kellaher

Foghorn Therapeutics shares rose sharply in premarket trading Monday after the clinical-stage biotechnology company said the U.S. Food and Drug Administration has lifted a clinical hold on a study of its FHD-286.

The Cambridge, Mass., company said it expects to launch a Phase 1 study of FHD-286 in the third quarter.

Foghorn last August said the FDA had placed a full clinical hold on the Phase 1 monotherapy dose escalation study of FHD-286 in acute myelogenous leukemia and myelodysplastic syndrome due to suspected cases of fatal differentiation syndrome believed to be associated with FHD-286 treatment.

The company said it has amended the trial protocol, and that it now plans to study FHD-286 in combination with decitabine or cytarabine in relapsed and/or refractory acute myelogenous leukemia patients .

Foghorn shares, which closed Friday at $7.10, were recently up more than 18% to $8.40 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

June 05, 2023 07:52 ET (11:52 GMT)

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