Mirum Pharmaceuticals’ LIVMARLI (maralixibat oral solution) Receives Positive Reimbursement Recommendation by Canada’s CADTH for Patients with Cholestatic Pruritus in Alagille Syndrome
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced data presented during the European Association for the Study of the Liver (EASL) Congress 2023, taking place in Vienna, Austria.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that data from LIVMARLI® (maralixibat) oral solution clinical studies evaluating patients with Alagille syndrome (ALGS) were published in Hepatology. LIVMARLI is the first and only approved treatment for cholestatic pruritus in patients with Alagille syndrome three months of age and older.
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that on May 10, 2023, the Compensation Committee of Mirum’s Board of Directors granted inducement awards consisting of non-qualified stock options to purchase 20,850 shares of common stock and 10,430 restricted stock units (“RSUs”) to five new employees under Mirum’s 2020 Inducement Plan. The Compensation Committee of Mirum’s Board of Directors approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a reduction in age from one year to three months for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). The label expansion was based on data from the RISE study which characterized the safety and tolerability of LIVMARLI in infants under one year of age with ALGS.
Mirum Pharmaceuticals’ LIVMARLI (maralixibat) Approved by the European Commission for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome Two Months and Older
BEIJING & BURLINGTON, Mass.--(BUSINESS WIRE)--CANbridge Pharmaceuticals Inc. (HKEX:1228), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative rare disease and rare oncology therapies, announced that the company’s partner Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) reported positive topline data from its Phase 3 MARCH study evaluating the safety and efficacy of LIVMARLI® (maralixibat) oral solution in patients with progressive familial intrahepatic cholestasis (PFIC). PFIC is included in the 121 Rare Disease List published in 2018 by Chinese authorities. CANbridge holds the exclusive right to develop and commercialize maralixibat (CAN108) in Greater China for three liver diseases: biliary atresia (BA), Alagille syndrome (ALGS) and PFIC. CANbridge is overseeing the Phase 2 EMBARK study of CAN108 in BA in China. CAN108 has been approved to treat Alagille syndrome under the Early and Pilot Implementation Policy in the Boao Lecheng International Medical Tourism Pilot Zone, in China.
Therapeutic wins for rare liver diseases are becoming common of late as Mirum Pharmaceuticals' Livmarli (maralixibat) oral solution met its primary endpoint in a Phase III study in progressive familial intrahepatic cholestasis (PFIC).
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced positive topline results from its pivotal Phase 3 MARCH study evaluating LIVMARLI® (maralixibat) oral solution in 93 patients with progressive familial intrahepatic cholestasis (PFIC) in a broad range of subtypes, age one to 17 years. The primary endpoint of improvement in pruritus severity in PFIC2 was statistically significant (p=0.0098).
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced two global advancements for LIVMARLI® (maralixibat) oral solution, an oral minimally absorbed ileal bile acid transporter (IBAT) inhibitor currently approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older.