HLB said the FDA (U.S. drug regulator) has conditionally accepted LYRFIGTU as the product name for Lirafugratinib, a bile duct cancer treatment being developed by its U.S. subsidiary Elevar Therapeutics. The name will become official if the FDA grants final approval, with a decision scheduled for September 25. Lirafugratinib is an oral small-molecule targeted cancer drug designed to selectively inhibit FGFR2, a cancer-causing genetic mutation. The FDA designated it an Orphan Drug in 2022, granted Innovative Therapy designation in 2023 and selected it for Priority Review in March this year. In earlier global Phase 1/2 trials, the objective response rate was 46.5% among bile duct cancer patients with FGFR2 fusion or rearrangement, while the median duration of response was 11.8 months. Elevar representative Kim Dong-geon said the company is working toward final approval and preparing for a swift launch to offer bile duct cancer patients a new treatment option.