Terns Receives FDA Breakthrough Therapy Designation for TERN-701
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 27 2026
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Source: Newsfilter
- FDA Breakthrough Designation: Terns Pharmaceuticals announced that its oral allosteric BCR::ABL1 inhibitor TERN-701 has received Breakthrough Therapy Designation from the FDA for adult patients with Ph+ CML in chronic phase previously treated with two or more TKIs, indicating significant clinical potential.
- Clinical Trial Progress: TERN-701 has shown promising efficacy in the ongoing CARDINAL clinical trial, with encouraging rates of major molecular response and deep molecular response observed at week 24, particularly in patients with treatment failure, highlighting its importance in treatment options.
- Safety and Tolerability: The majority of treatment-emergent adverse events were reported as low grade, with a low incidence of severe adverse events, demonstrating TERN-701's advantages in safety and tolerability, potentially offering better treatment options for CML patients.
- Strategic Partnership Outlook: This FDA designation, along with Merck's agreement to acquire Terns, may accelerate TERN-701's advancement to pivotal trial stages, further propelling its commercialization efforts to meet significant unmet medical needs.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
