The U.S. Food and Drug Administration approved Lypiktu, also known as lirafugratinib, for second-line treatment of bile duct cancer in patients with confirmed FGFR2 gene fusions or rearrangements. Developed and commercialized by HLB subsidiary Elevar Therapeutics, the oral drug selectively inhibits FGFR2 and is planned for U.S. launch in the fourth quarter of 2026. In the Phase 1/2 ReFocus trial, the approved population recorded a 45.7% objective response rate and an 11.8-month median duration of response; median progression-free survival was 11.3 months. The approval marks the first direct U.S. approval of a novel cancer drug filed by a South Korean company. Elevar acquired global development and commercialization rights from Relay Therapeutics in 2024, filed for European approval in September 2026 and is studying the drug in other FGFR2-altered solid tumors. Commercial prospects will depend partly on its performance against existing FGFR-targeting treatments and the smaller population eligible for FGFR2-directed therapy.