Terns Pharmaceuticals Inc.
FDA Grants Breakthrough Therapy Designation to Terns Pharmaceuticals' TERN-701 for Chronic Myeloid Leukemia
Summary
On April 27, 2026, Terns Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (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 leukemia (Ph+CML) in the chronic phase without the T315I mutation previously treated with two or more tyrosine kinase inhibitors (TKIs). This designation is based on data from the ongoing Phase 1/2 CARDINAL clinical trial, which has shown promising activity with encouraging rates of major molecular response and deep molecular response observed at week 24. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations. The Breakthrough Therapy Designation is intended to expedite the development and review of potential new medicines designed to treat serious conditions or address significant unmet medical needs.
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About Terns Pharmaceuticals Inc.
Terns Pharmaceuticals Inc. is a biopharmaceutical company dedicated to the discovery and development of novel therapeutic candidates targeting liver disease and oncology. Its primary function is to advance its pipeline of clinical and preclinical drug candidates that address significant unmet medical needs. One of the company's main focuses is on non-alcoholic steatohepatitis (NASH), a progressive liver disease. Through innovative approaches, Terns Pharmaceuticals explores various mechanisms to treat NASH, including small molecules designed to reduce liver inflammation and fibrosis. Beyond liver disease, the company is expanding its platform to include oncology, diversifying its impact in the healthcare industry. As a key player in the biopharmaceutical sector, Terns Pharmaceuticals Inc. contributes to the growing landscape of targeted therapies. With a dedicated emphasis on research and development, the company plays an essential role in pushing the boundaries of treatment options, potentially transforming the management of chronic liver diseases and cancer.
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