Elevar Therapeutics, a majority-owned subsidiary of HLB Co., Ltd., submitted a marketing authorization application to the European Medicines Agency for lirafugratinib as a second-line treatment for patients with advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. The filing follows Elevar's January 2026 New Drug Application to the U.S. Food and Drug Administration, which received Priority Review and has a Prescription Drug User Fee Act target action date of Sept. 25, 2026. Results from the Phase 1/2 ReFocus study showed a 46.5% objective response rate, an 11.8-month median duration of response, 11.3-month median progression-free survival and 22.8-month median overall survival among previously treated patients. Lirafugratinib is an oral, irreversible and highly selective FGFR2 inhibitor designed to distinguish it from pan-FGFR therapies that also inhibit FGFR1, FGFR3 and FGFR4. Elevar reported hyperphosphatemia and diarrhea rates of 20.7% and 21.6%, respectively. The company is also enrolling patients globally in the Phase 2 ReFocus202 study, which is evaluating the drug in other solid tumors with FGFR2 fusions or rearrangements.