27 April 2026 - Terns Pharmaceuticals today announced that the US FDA granted breakthrough therapy designation to TERN-701, a novel, oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in the chronic phase without the T315I mutation previously treated with two or more tyrosine kinase inhibitors.

TERN-701 breakthrough therapy designation is based on data from the ongoing Phase 1/2 CARDINAL clinical trial of TERN-701 in patients with chronic myeloid leukaemia previously treated with at least one prior tyrosine kinase inhibitor and who experienced treatment failure, sub-optimal response or treatment intolerance.

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