Shares of Black Diamond Therapeutics Inc. jumped more than 20% in premarket trading Tuesday after the precision-oncology company received U.S. Food and Drug Administration approval for a study of its BDTX-1535 cancer therapy.
The Cambridge, Mass., company said it expects to initiate a Phase 1 study of BDTX-1535 in the first quarter and to provide a clinical update in the second half of 2023.
Black Diamond said BDTX-1535 is designed as an irreversible, mutant selective, brain-penetrant inhibitor of oncogenic mutations of epidermal growth factor receptor, or EGFR, expressed in glioblastoma multiforme and intrinsic and acquired resistance EGFR mutations in non-small cell lung cancer.
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