Welcome to our dedicated page for Mirum Pharmaceuticals news (Ticker: MIRM), a resource for investors and traders seeking the latest updates and insights on Mirum Pharmaceuticals stock.
Mirum Pharmaceuticals, Inc. develops and commercializes medicines for rare diseases, with recurring updates centered on product sales, clinical readouts, regulatory interactions and employee equity grants. The company’s commercial portfolio includes LIVMARLI® (maralixibat) for Alagille syndrome and progressive familial intrahepatic cholestasis, CHOLBAM® (cholic acid) for bile-acid synthesis disorders, and CTEXLI® (chenodiol) for cerebrotendinous xanthomatosis.
News about MIRM also covers clinical-stage programs including volixibat, an IBAT inhibitor for primary sclerosing cholangitis and primary biliary cholangitis; brelovitug, a monoclonal antibody designed to bind hepatitis B surface antigen for chronic hepatitis delta virus; and MRM-3379, a PDE4D inhibitor for Fragile X syndrome. Company updates report financial results, pipeline licensing activity and inducement awards under Nasdaq Listing Rule 5635(c)(4).
Mirum Pharmaceuticals (NASDAQ: MIRM) announced on December 9, 2022, that its Compensation Committee granted inducement awards comprising non-qualified stock options for 38,200 shares and 19,100 restricted stock units (RSUs) to seven new employees. The stock options have an exercise price of $18.16 per share, vesting over four years. The RSUs will vest over three years. This grant is in accordance with Nasdaq Listing Rule 5635(c)(4) and is part of Mirum's strategy to attract talent in the biopharmaceutical sector, focusing on rare liver diseases.
Mirum Pharmaceuticals, Inc. (MIRM) announced the discontinuation of the OHANA study of volixibat in intrahepatic cholestasis of pregnancy due to enrollment challenges. Despite showing significant reductions in serum bile acids and pruritus in patients, the company prioritizes other programs. Mirum expects to achieve $70 million in net product revenue for 2022, focusing on the upcoming approval of LIVMARLI in Europe and milestones for other programs in 2023. Key upcoming events include regulatory submissions and interim analyses for volixibat in various conditions.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) will participate in two investor conferences on November 29, 2022. The first is the Evercore ISI HealthCONx Conference with a presentation at 8:00 a.m. ET, followed by the Piper Sandler 34th Annual Healthcare Conference with a presentation at 3:30 p.m. ET. Mirum is focused on rare liver diseases and has an approved treatment, LIVMARLI®, for cholestatic pruritus in Alagille syndrome patients. The company is also advancing its pipeline, including treatments for progressive familial intrahepatic cholestasis and biliary atresia.
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.