Business
Mirum Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Business Update
- NDA for maralixibat for cholestatic pruritus in Alagille syndrome under priority review; PDUFA date is September 29, 2021 - Commercial preparations
About this update from Mirum Pharmaceuticals, Inc.
[{"type":"text","content":"\n- NDA for maralixibat for cholestatic pruritus in Alagille syndrome under priority review; PDUFA date is September 29, 2021\n- Commercial preparations complete in anticipation of U.S. launch of maralixibat in ALGS\n- Conference call to provide business update today, August 5 at 1:30 p.m. PT/4:30 p.m. ET\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nMirum Pharmaceuticals, Inc. (Nasdaq: MIRM), today reported financial results for the quarter ended June 30, 2021 and provided a business update.\n\n“We are pleased with the progress we have made in the last quarter as we prepare for the potential FDA approval of maralixibat and advance our late-stage clinical development pipeline,” said Chris Peetz, president and chief executive officer at Mirum. “Alagille syndrome is a terrible disease, and we know patients and physicians are waiting for treatment options. We are launch ready in the United States and have amplified our reach to patients globally with our expanded access program and recent partnerships to accelerate potential approvals in a number of markets.”\n\nRecent Key Operational Highlights \n\n\nEntered into an exclusive licensing agreement with GC Pharma to develop and commercialize maralixibat for rare liver diseases in South Korea.\n\n\nPresented maralixibat transplant-free survival data for progressive familial intrahepatic cholestasis type 2 (PFIC2) and long-term safety analyses for Alagille syndrome (ALGS) at the 6th World Congress of Pediatric Gastroenterology, Hepatology and Nutrition (WCPGHAN) Annual Meeting 2021.\n\n\nAppointed Carol L. Brosgart, M.D. as an independent director to the Board of Directors.\n\n\nPresented an integrated safety analysis of maralixibat in patients with ALGS and unveiled a multi-national survey of patient reported outcomes from pregnant women with intrahepatic cholestasis of pregnancy (ICP) at the EASL International Liver Congress 2021.\n\n\nFinancial Results \n\n\nLicensing revenue for the quarter ended June 30, 2021 was $11.0 million, which was associated with our license and collaboration agreement with CANbridge Pharmaceuticals, Inc., compared to none for the second quarter of 2020.\n\n\nTotal operating expenses for the quarter ended June 30, 2021 were $48.4 million, compared to $23.6 million for the second quarter of 2020.\n\n\nResearch and development expenses for the quarter ended Jun...