Mirum Pharma Out-Licenses Maralixibat Rights To GC Pharma in South Korea

  • Mirum Pharmaceuticals Inc MIRM and GC Pharma have entered into an exclusive licensing agreement to develop and commercialize Mirum's maralixibat in South Korea. 
  • Maralixibat is an investigational, orally administered medication being evaluated in Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia (BA).
  • The FDA has accepted a maralixibat marketing application for cholestatic pruritus in patients with ALGS under priority review. 
  • The European Medicines Agency is reviewing maralixibat for the treatment of PFIC. 
  • Mirum has commenced a global Phase 2b maralixibat study (EMBARK) for the treatment of BA.
  • Under the terms of the licensing agreement, Mirum will receive an upfront payment of $5 million and payments undisclosed milestone payments, with tiered double-digit royalties based on net product sales in the region.
  • Price Action: MIRM shares closed at $15.24 on Monday.
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