Why Foghorn Therapeutics (FHTX) Stock Is Plunging Today - Foghorn Therapeutics (NASDAQ:FHTX)

The FDA has put Foghorn Therapeutics Inc's FHTX study on partial hold after a patient had a severe heart-related safety event.
The company said to pause enrollment on its Phase 1 trial of FHD-609 in patients with synovial sarcoma and SMARCB1-deleted tumors.
A sarcoma patient who received the second-highest dose of its drug candidate had a grade 4 QTc prolongation event that could lead to a life-threatening arrhythmia (irregular heartbeat).
Foghorn said, "Patients in the affected cohort were dose reduced, and additional safety measures have been discussed with and provided to the study investigators."
Enrollment in the dose escalation portion of the study has been completed, and a maximum tolerated dose has been identified. The company is not at this time planning to pursue a dose expansion study independently.
In May 2022, the FDA instituted a partial clinical hold on Foghorn Therapeutics' Phase 1 dose-escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).
The FDA requested a review of the safety database, risk mitigation strategies, and clinical activity breakdown across dose levels.
In August 2022, the FDA placed a full clinical hold on the Phase 1 dose escalation study of FHD-286.
The company anticipates providing clarity on the development path for FHD-286 in AML/MDS in 1H of 2023.
Price Action: FHTX shares are down 17.7% at $5.53 on the last check Monday.

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