Mirum Pharmaceuticals Stock Price, News & Analysis

Mirum Pharmaceuticals reported net product sales of $18.8 million for LIVMARLI in Q3 2022, totaling $47.2 million year-to-date. The company raised its full-year sales guidance for LIVMARLI to $70 million. Positive clinical milestones include a favorable CHMP opinion for Alagille syndrome and successful topline results from the Phase 3 MARCH study in PFIC. Operating expenses rose to $51.7 million, while the net loss decreased to $35.7 million. The company ended Q3 with $285.3 million in cash and equivalents.

Mirum Pharmaceuticals reported significant findings from the Phase 3 MARCH study of LIVMARLI (maralixibat), a treatment for progressive familial intrahepatic cholestasis (PFIC). The study met primary and secondary endpoints, showing over 60% response in pruritus and half in serum bile acids versus placebo. Additionally, safety data from the RISE study indicates tolerability in infants with Alagille syndrome (ALGS) starting at two months. Mirum plans to discuss these results with regulatory bodies, highlighting the potential market impact of LIVMARLI.

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) will report its third quarter financial results on November 9, 2022, alongside a conference call to discuss corporate progress and the MARCH Phase 3 study on LIVMARLI. Guest speaker, Dr. Richard J. Thompson, will join the discussion.

The conference call is scheduled for 8:00 a.m. ET. Investors can access the call via dial-in or webcast. Mirum's medication, LIVMARLI, is approved in the U.S. for treating cholestatic pruritus in patients with Alagille syndrome. A decision from the European Commission on LIVMARLI is anticipated by year-end 2022.

Mirum Pharmaceuticals (MIRM) announced significant upcoming presentations at The Liver Meeting® from November 4-7, 2022, in Washington, D.C. The company will showcase data from LIVMARLI® (maralixibat) oral solution, including a late-breaking oral presentation on the phase 3 MARCH study in progressive familial intrahepatic cholestasis (PFIC) and a poster on the RISE study in infants with Alagille syndrome (ALGS). LIVMARLI is currently the only FDA-approved medication for cholestatic pruritus in ALGS patients aged one year and older.

Mirum Pharmaceuticals has announced positive topline results from its Phase 3 MARCH study of LIVMARLI® (maralixibat) for treating progressive familial intrahepatic cholestasis (PFIC). This achievement may enhance treatment options for patients with PFIC, a rare liver disease. CANbridge holds exclusive rights to develop maralixibat in Greater China for PFIC and other liver diseases. The drug is also under clinical evaluation for biliary atresia and has received Breakthrough Therapy Designation from the FDA.

Mirum Pharmaceuticals reported positive topline results from the Phase 3 MARCH study of LIVMARLI® (maralixibat) for treating progressive familial intrahepatic cholestasis (PFIC). The study demonstrated a statistically significant improvement in pruritus severity for PFIC2 patients (p=0.0098) and significant reductions in serum bile acids and total bilirubin levels. Mirum plans to submit these findings to regulatory agencies. The safety profile was consistent with earlier studies, with diarrhea being the most common side effect but mostly mild and transient.

Mirum Pharmaceuticals (NASDAQ: MIRM) announced significant findings from its ICONIC study published in the Journal of Pediatrics. The analysis of 27 patients with Alagille syndrome treated with LIVMARLI® (maralixibat) showed meaningful improvements in quality of life and sleep by reducing pruritus. At week 48, responders indicated a clinically significant rise in health-related quality of life (HRQoL) scores. LIVMARLI is the only FDA-approved treatment for cholestatic pruritus in ALGS patients aged one year and older.

Mirum Pharmaceuticals announced significant advancements for LIVMARLI (maralixibat), an oral treatment for cholestatic pruritus due to Alagille syndrome (ALGS). The European Committee for Medicinal Products for Human Use recommended approval for patients two months and older, with a decision from the European Commission expected by year-end 2022. Additionally, LIVMARLI received approval in Israel for patients one year and older. The pivotal ICONIC study demonstrated durable improvements in symptoms over five years. LIVMARLI is the first targeted treatment for ALGS in Europe.

Mirum Pharmaceuticals (NASDAQ: MIRM) showcased significant findings at the NASPGHAN Annual Meeting regarding maralixibat's long-term benefits for patients with Alagille syndrome (ALGS). Data presented highlighted a 70% reduction in clinical events over six years and substantial improvements in growth metrics over four years. Additionally, a multi-national analysis revealed significant caregiver impacts due to ALGS. The company continues to pursue further evaluations of maralixibat and plans a symposium on its clinical benefits.