Adagene reports mid-2026 results, muzastotug data across CRC and HCC trials

Adagene Inc. reported financial results for the six months ended June 30, 2026 on August 12, 2026, alongside updates on its lead program muzastotug (ADG126), a masked anti-CTLA-4 antibody.

In the Phase 1b/2 trial combining muzastotug with pembrolizumab in microsatellite stable colorectal cancer, the combined 20 mg/kg cohorts achieved a confirmed overall response rate of 31%, with median progression-free survival of 6.7 months and median overall survival not yet reached.¹ The 10 mg/kg cohorts showed a lower response: an overall response rate of 13%, median progression-free survival of 4.8 months, and median overall survival of 19.8 months.¹ Across all 67 patients in the study, the overall discontinuation rate was 4%, with no dose limiting toxicities and no Grade 4 or 5 treatment-related adverse events reported, while Grade 3 events occurred in 15% of the 10 mg/kg cohorts and 38% of the 20 mg/kg cohorts.¹

A randomized Phase 2 trial is enrolling to select a dose regimen, and results are expected in the first half of 2027.¹ A follow-on registration trial is planned once a recommended dose regimen is chosen, a plan supported by the therapy's Fast Track designation and prior alignment with the FDA under its Project Optimus initiative.¹

In a separate triple-combination study in first-line liver cancer with atezolizumab and bevacizumab, six patients treated with muzastotug showed a 66.7% response rate by modified RECIST criteria, or 50% by standard RECIST, with median progression-free survival of 8.2 months and median overall survival exceeding 22 months.¹

Adagene also disclosed cash and cash equivalents of $127.9 million as of June 30, 2026, up from $74.5 million at year-end 2025¹, with runway now extending into late 2028.¹ Net loss attributable to shareholders was $16.4 million for the six-month period, compared to $13.5 million a year earlier.¹