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Mirum (MIRM)-Takeda Collaborate for Liver Disease Drug in Japan
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Mirum Pharmaceuticals, Inc. (MIRM - Free Report) announced that it has entered into an exclusive licensing agreement with Takeda Pharmaceutical (TAK - Free Report) for the development and commercialization of its lead product candidate, maralixibat, for treating Alagille syndrome (“ALGS”), progressive familial intrahepatic cholestasis (“PFIC”) and biliary atresia, in Japan.
Per the latest deal, Takeda will lead the regulatory approval and commercialization of maralixibat in Japan, and will also be responsible for conducting studies in cholestatic indications.
The above partnership will leverage Takeda’s expertise and leadership in rare disease, gastroenterology and hepatology to advance maralixibat for rare pediatric liver diseases in Japan.
If successfully developed and upon potential approval, maralixibat can serve an area of significant unmet medical need for patients with cholestatic diseases such as ALGS and PFIC, in Japan.
Shares of Mirum have rallied 9.4% so far this year against the industry’s decrease of 1.4%.
Image Source: Zacks Investment Research
In March 2021, the FDA accepted the new drug application (“NDA”) for maralixibat to treat cholestatic pruritus in patients with ALGS aged one year and above. With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Sep 29, 2021.
Currently there is no approved therapy for ALGS, a rare liver disease.
Earlier this month, Mirum submitted the marketing authorization application for maralixibat to the European Medicines Agency for the treatment of cholestatic liver disease in patients with ALGS.
Spero Therapeutics’ loss per share estimates have narrowed 8.2% for 2021 and 10.6% for 2022 over the past 60 days.
Corvus Pharmaceuticals’ loss per share estimates have narrowed 13.9% for 2021 and 7.2% for 2022, over the past 60 days. The stock has skyrocketed 139.6% year to date.
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Mirum (MIRM)-Takeda Collaborate for Liver Disease Drug in Japan
Mirum Pharmaceuticals, Inc. (MIRM - Free Report) announced that it has entered into an exclusive licensing agreement with Takeda Pharmaceutical (TAK - Free Report) for the development and commercialization of its lead product candidate, maralixibat, for treating Alagille syndrome (“ALGS”), progressive familial intrahepatic cholestasis (“PFIC”) and biliary atresia, in Japan.
Per the latest deal, Takeda will lead the regulatory approval and commercialization of maralixibat in Japan, and will also be responsible for conducting studies in cholestatic indications.
The above partnership will leverage Takeda’s expertise and leadership in rare disease, gastroenterology and hepatology to advance maralixibat for rare pediatric liver diseases in Japan.
If successfully developed and upon potential approval, maralixibat can serve an area of significant unmet medical need for patients with cholestatic diseases such as ALGS and PFIC, in Japan.
Shares of Mirum have rallied 9.4% so far this year against the industry’s decrease of 1.4%.
Image Source: Zacks Investment Research
In March 2021, the FDA accepted the new drug application (“NDA”) for maralixibat to treat cholestatic pruritus in patients with ALGS aged one year and above. With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Sep 29, 2021.
Currently there is no approved therapy for ALGS, a rare liver disease.
Earlier this month, Mirum submitted the marketing authorization application for maralixibat to the European Medicines Agency for the treatment of cholestatic liver disease in patients with ALGS.
Zacks Rank & Stocks to Consider
Mirum currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Spero Therapeutics, Inc. (SPRO - Free Report) and Corvus Pharmaceuticals, Inc. (CRVS - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Spero Therapeutics’ loss per share estimates have narrowed 8.2% for 2021 and 10.6% for 2022 over the past 60 days.
Corvus Pharmaceuticals’ loss per share estimates have narrowed 13.9% for 2021 and 7.2% for 2022, over the past 60 days. The stock has skyrocketed 139.6% year to date.