TERN-701 is a highly selective allosteric BCR-ABL inhibitor with a potentially best-in-disease profile that could meaningfully improve upon the efficacy, safety and convenience of existing CML treatments. The Phase 1 CARDINAL trial showed a 75% cumulative major molecular response (MMR) rate by 24 weeks with 100% MMR durability and encouraging safety across doses.
Cyborg Score Rationale
The company raised $747.5 million in a December 2025 capital offering, with expected cash runway into 2028. Multiple key milestones planned for 2026 include pivotal dose selection, FDA End of Phase 2 meeting in mid-2026, and initiation of a pivotal trial in late 2026/early 2027.
Top Insights
Unprecedented Phase 1 CML efficacy data showing 75% MMR achievement by 24 weeks in higher dose cohorts with durable responses and favorable safety profile
$747.5 million capital raise closed December 2025 provides extended runway to fund development and manufacturing
Multiple transformational milestones planned for 2026: pivotal dose selection, FDA regulatory interaction mid-2026, and pivotal trial initiation targeting faster enrollment than historical CML standards
Company discontinued obesity drug program after Phase 2 trial showed modest efficacy and safety concerns, allowing focused strategy on high-potential TERN-701
Named Competitors
Dasatinib — Second-generation BCR-ABL tyrosine kinase inhibitor for CML
Nilotinib — Second-generation BCR-ABL tyrosine kinase inhibitor for CML
Bosutinib — Second-generation BCR-ABL tyrosine kinase inhibitor for CML
Recent Developments
(February 2026) Equity inducement grants to new employees signal ongoing team expansion
(December 2025) Public offering of 18.7M shares at $40/share raising $747.5M gross proceeds
(December 2025) ASH 2025 abstract presented expanded CARDINAL Phase 1/2 data with 75% MMR at 24 weeks in higher doses
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