Mirum Pharmaceuticals' LIVMARLI Receives FDA Approval for Treatment of Cholestatic Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis [Yahoo! Finance]
Mirum Pharmaceuticals, Inc. - common stock (MIRM)
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Source: Yahoo! Finance
Label covers broad range of PFIC subtypes Immediate launch and availability for eligible patients in the U.S. FOSTER CITY, Calif., March 13, 2024 BUSINESS WIRE )--Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC). Mirum has also submitted an additional supplemental new drug application (sNDA) to introduce a higher concentration formulation of LIVMARLI, used during the MARCH study, to enable label expansion for younger patients with PFIC, later this year. LIVMARLI is also approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. (three months and older), Europe (two months and older), in Canada and other regions globally. "LIVMARLI has the potential to have a transformational impact for
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MIRM
Earnings
- 11/2/23 - Beat
MIRM
Sec Filings
- 4/23/24 - Form ARS
- 4/23/24 - Form DEFA14A
- 4/23/24 - Form DEF
- MIRM's page on the SEC website