On February 10, 2026, Abbisko Cayman Limited (2256) announced that its subsidiary, Abbisko Therapeutics, received Fast Track Designation from the U.S. FDA for irpagratinib (ABSK-011), a highly selective small-molecule FGFR4 inhibitor. This development targets patients with hepatocellular carcinoma (HCC) showing FGF19 overexpression who have undergone prior treatment with immune checkpoint inhibitors and multi-targeted kinase inhibitors.

Phase I results presented at the 2024 ESMO Annual Congress showed irpagratinib monotherapy achieved an objective response rate of 46.7% and median progression-free survival of 5.5 months in advanced HCC patients who had failed earlier treatments. A subsequent combination study with atezolizumab, reported at the 2025 ESMO-GI forum, indicated an objective response rate above 50% and a median progression-free survival exceeding seven months in treatment-naïve cases and those previously treated with checkpoint inhibitors.

Abbisko Therapeutics also secured Breakthrough Therapy Designation for irpagratinib from China’s NMPA in May 2025 and initiated a pivotal registration trial nationwide. No FGFR4 inhibitor has yet been approved globally, and this Fast Track status is expected to streamline further clinical development and regulatory review for irpagratinib in HCC. Abbisko Cayman Limited notes that there is no guarantee of eventual successful marketing of the product.