Mirum Pharmaceuticals Stock Price, News & Analysis

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.

Mirum Pharmaceuticals, Inc. (MIRM) announced that its Compensation Committee granted inducement awards to nine new employees on October 10, 2022. This includes non-qualified stock options to purchase 52,650 shares and 26,400 restricted stock units (RSUs) under Mirum’s 2020 Inducement Plan. The stock options have an exercise price of $18.22 and will vest over four years. RSUs will vest over three years. The awards are designed to incentivize employee retention and align their interests with shareholders.

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) will present three research posters and host a symposium at the NASPGHAN Annual Meeting in Orlando, Florida, from October 12-16, 2022. Key presentations include:

• Poster #290: Maralixibat improves growth in Alagille Syndrome patients.
• Poster #291: Improved event-free survival observed in maralixibat-treated patients.
• Poster #552: Caregiver burden analysis for Alagille Syndrome.

The symposium, “Beyond Itch,” will occur on October 13, featuring several distinguished speakers.

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) announced on September 10-11, 2022, the granting of inducement awards to 11 new employees, comprising 47,750 stock options and 23,900 restricted stock units (RSUs). The stock options have an exercise price of $25.15, equal to the closing price on September 9, 2022, and will vest over four years. The RSUs will vest over three years. This award follows Nasdaq Listing Rule 5635(c)(4) and aims to attract talent to support the company's growth in treating rare diseases.

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced its participation in key investor conferences, including Citi's 17th Annual BioPharma Conference on September 7, 2022, H.C. Wainwright's Global Investment Conference on September 12-13, 2022, and Baird's Global Healthcare Conference on September 14, 2022. The company focuses on rare and orphan diseases, notably with its approved treatment LIVMARLI® for Alagille syndrome. Mirum is also advancing its pipeline with investigational therapies targeting debilitating liver diseases, including ongoing clinical trials for pediatric and adult conditions.