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HLB's Lyrfigtu wins FDA approval for FGFR2-altered bile duct cancer
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Fusion42 · 24 September 2026 · Fusion42 review
HLB's U.S. subsidiary Elevar Therapeutics has won FDA approval for Lyrfigtu (lirafugratinib), an FGFR2-targeted drug to treat previously treated patients with FGFR2 fusion- or rearrangement-positive cholangiocarcinoma, marking a notable entry of a Korean biopharma into U.S. oncology market with plans to expand further in Europe and other FGFR2-driven cancers.
This Wire brief sits within Fusion42's coverage of Biotech, and 6 sources have reported it between 21 Sep 2026 and 28 Sep 2026.
◆ ◆ The Wire takeaway
You have a new path to market with a Korean biopharma FDA approval setting a precedent. This could open doors for competition and partnerships around FGFR2-targeted cancer drugs in the U.S.
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6 sources · first reported 21 Sep 2026 · latest 28 Sep 2026
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