HLB has secured U.S. Food and Drug Administration approval for Lyrfigtu, or pemigatinib, an oral targeted treatment for adults with previously treated, unresectable bile duct cancer whose tumors have confirmed FGFR2 gene fusions or rearrangements. The approval was supported by a Phase 1/2 study of 116 patients, in which 46% achieved qualifying tumor shrinkage and the median response duration was 11.8 months. The FDA also required a randomized postmarketing trial comparing the approved 70-mg daily dose with lower doses, to be completed by November 2031. Elevar Therapeutics, HLB's U.S. subsidiary, acquired pemigatinib development and commercialization rights from Relay Therapeutics in December 2024 for $5 million upfront, with potential milestones of up to $500 million and sales royalties. Elevar aims to launch the drug in the United States in the fourth quarter. The decision provides HLB with an approved oncology drug while its rivoceranib-camrelizumab liver cancer combination remains pending after a third complete response letter in July over manufacturing and quality-control issues.