Foghorn Therapeutics Inc.’s stock FHTX slid 21% in premarket trade Monday, after the biotech said the Food and Drug Administration has placed a partial hold on a cancer trial. The company is pausing enrollment in the trial of its FHD-609 therapy in synovial sarcoma and SMARCB1-deleted tumors. Synovial sarcoma is a rare cancer that affects the tissue around the joints. The move is due to a grade 4 QTc prolongation event in a patient at the second highest dose. That means the patient showed signs or symptoms of serious arrhythmia. “Patients in the affected cohort were dose reduced and additional safety measures have been discussed with and provided to the study investigators,” the company said in a statement. The FDA has placed the study on partial clinical hold and will allow patients currently enrolled and benefiting from the therapy to continue dosing and remain on FHD-609. The Cambridge, Mass.-based company is not at this time planning to pursue a dose expansion study independently. The stock has gained 5% in the year to date, while the S&P 500 SPX has gained 8%.
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