– $76 million in total revenue and $74 million net product sales anticipated for LIVMARLI for 2022, preliminary and unaudited – sNDA for LIVMARLI in PFIC submission planned for first quarter 2023 – Multiple data analyses planned in 2023 advancing late-stage cholestasis programs FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today provided a preview…
Apr 12, 2023 FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced estimated revenue, including net product sales, and cash balance for the first quarter 2023. The company’s preliminary unaudited financial results for the first quarter of 2023 include: Additionally, the company updated its guidance for the VISTAS Phase 2b clinical trial evaluating volixibat…
Oct 02, 2023 – Primary endpoint met (p<0.0001); 20-fold difference in urine bile alcohols – First and only prospective, controlled clinical trial in CTX – Plasma cholestanol endpoint met (p=0.0083), the driver of poor outcomes in CTX patients – Data to be submitted for presentation at future medical congress – Mirum plans to file an NDA with the U.S. FDA…
Oct 17, 2023 FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has extended the review of the Supplemental New Drug Application (sNDA) for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The new Prescription Drug…
May 11, 2023 FOSTER CITY, Calif.–(BUSINESS WIRE)– Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced it has completed enrollment of its Phase 2b EMBARK study for pediatric patients with biliary atresia, the most common indication for pediatric liver transplant. The EMBARK study is a global, double-blind, randomized, placebo-controlled, 26-week trial evaluating the efficacy and safety of LIVMARLI®…
– LIVMARLI immediately available for prescribing for patients three months of age and older 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…
