Mirum Pharmaceuticals Stock Price, News & Analysis

Mirum Pharmaceuticals (Nasdaq: MIRM) announced its participation at the J.P. Morgan Healthcare Conference, scheduled for January 9-12, 2023, in San Francisco, CA. Mirum will present on January 10 from 1:30-2:10 p.m. PT.

Mirum focuses on developing therapies for rare liver diseases, with its approved treatment LIVMARLI® for cholestatic pruritus due to Alagille syndrome. The company has a pipeline of investigational treatments for liver diseases in children and adults.

Mirum Pharmaceuticals announced the addition of Lon Cardon, Ph.D., to its Board of Directors, where he will also serve on the Nominating and Governance Committee. Dr. Cardon brings 30 years of experience in drug discovery and development, previously holding senior roles at BioMarin and GlaxoSmithKline. Concurrently, Carol Brosgart, M.D., steps down from the Board to become a senior advisor. The company highlights Dr. Cardon's expertise as vital for growth in treating rare diseases, particularly with its current products and pipeline.

Mirum Pharmaceuticals announced that the European Commission has granted marketing authorization for LIVMARLI® (maralixibat) to treat cholestatic pruritus in patients with Alagille syndrome aged two months and older. This marks the first approval in both the U.S. and Europe for this condition. The approval is supported by over six years of clinical data showing improved survival rates and quality of life for patients. LIVMARLI is expected to launch in Germany in early 2023, with additional regulatory reviews ongoing in China, South Korea, and elsewhere.

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.