Mirum, Takeda Ink Maralixibat Licensing Pact In Japan

  • Mirum Pharmaceuticals Inc MIRM and Takeda Pharmaceutical Company Limited TAK have entered into an exclusive licensing agreement for maralixibat in Japan for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia (BA). 
  • Under the terms of the agreement, Takeda will be responsible for regulatory approval and commercialization of maralixibat in Japan. 
  • Takeda will also be responsible for the development, including conducting clinical studies in cholestatic indications.
  • Mirum has submitted a marketing application to the FDA for maralixibat for cholestatic pruritus in patients with Alagille syndrome. 
  • The application is currently under priority review with an FDA decision date of September 29. 
  • Mirum also recently submitted a European application for maralixibat for cholestatic liver disease in patients with ALGS.
  • Price Action: MIRM stock is up 0.95% at $19.18, and TAK stock is up 0.76% at $17.19 during the market session on the last check Tuesday.
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