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FDA nears decision as HLB plans US launch of bile duct cancer drug Ripictu
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Fusion42 · 21 September 2026 · Fusion42 review
HLB's US subsidiary Elevar Therapeutics is awaiting FDA approval for the bile duct cancer drug lirafugratinib, branded as Lyrfigtu, with a decision expected on September 25. The drug, targeting FGFR2 alterations, has shown promising clinical trial results and has received orphan and breakthrough therapy designations.
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
Your entry into US bile duct cancer treatment could open wide with FDA approval of lirafugratinib. Prepare your clinical partnerships and market strategy now to capitalise on this rare disease drug’s launch.
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6 sources · first reported 21 Sep 2026 · latest 28 Sep 2026
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