HLB Receives FDA Priority Review For Lirafugratinib

South Korea's HLB said on March 30, 2026 that its U.S. subsidiary Elevar Therapeutics received FDA acceptance of a new drug application and priority review for lirafugratinib, a targeted therapy for FGFR2-altered cholangiocarcinoma. The designation shortens review to six months with a decision expected Sept. 27, 2026; clinical data showed a 47% objective response rate versus 36%–42% for rival FGFR inhibitors, and HLB is preparing for potential approval and commercialization.