Business
Mirum Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update
- Third quarter 2023 total revenue of $47.7 million - Completed acquisition of CHENODAL® and CHOLBAM® - Announced positive Phase 3 RESTORE study results
About this update from Mirum Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Third quarter 2023 total revenue of $47.7 million\n- Completed acquisition of CHENODAL® and CHOLBAM®\n- Announced positive Phase 3 RESTORE study results evaluating CHENODAL (chenodiol) in patients with CTX; NDA filing expected in H1 2024\n- Conference call to provide business updates today, November 2 at 1:30 p.m. PT/4:30 p.m. ET\n\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nMirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today reported financial results for third quarter 2023 and provided a business update.\n\n\n“We made significant progress in the third quarter with record LIVMARLI revenues in both the United States and Internationally, the closing of the acquisition of CHENODAL and CHOLBAM and the positive top line results from the unblinding of the RESTORE trial of CHENODAL in CTX,” said Chris Peetz, president and chief executive officer at Mirum. “The company is well positioned to maintain this momentum with continued strong revenue growth and we look forward to multiple exciting upcoming clinical and regulatory catalysts.”\n\n\nLIVMARLI®: Continued growth in Alagille syndrome worldwide net sales and progressive familial intrahepatic cholestasis (PFIC) near-term label expansion opportunity\n\n\n\nThird quarter 2023 global net sales of $38.7 million grew 106% as compared to third quarter 2022.\n\n\n\nInternational commercial expansion ongoing with continued strong demand.\n\n\n\nPresented 15 oral and poster presentations on clinical data and real-world evidence validating LIVMARLI in patients with Alagille syndrome and PFIC at the North American Society for Pediatric, Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting.\n\n\n\nSupplemental New Drug Application (sNDA) for LIVMARLI in PFIC assigned Prescription Drug User Fee Act (PDUFA) date of March 13, 2024.\n\n\n\nCompleted acquisition of CHENODAL and CHOLBAM: establishes Mirum’s leading growth franchise in pediatric hepatology\n\n\n\nAcquired two therapies approved in the U.S.: CHOLBAM (cholic acid) for the treatment of bile acid synthesis disorders (BASD) and Zellweger spectrum disorders (ZSD), and CHENODAL, an approved medical necessity medicine for the treatment of cerebrotendinous xanthomatosis (CTX).\n\n\n\nAnnounced positive Phase 3 data from the landmark RESTORE study evaluating CHENODAL in patients with CTX. The Company expects to submit a New Drug ...