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 (MIRM) announced on March 10, 2023, that its Compensation Committee granted inducement awards to four new employees, comprising stock options for 40,050 shares and 20,050 restricted stock units (RSUs) under its 2020 Inducement Plan. Each option has an exercise price of $22.30, matching the closing price on the grant date, and will vest over four years. The RSUs will vest over three years. Mirum is dedicated to treating rare liver diseases, with its chief product, LIVMARLI, approved for cholestatic pruritus in patients with Alagille syndrome. The company is advancing two investigational treatments for liver diseases.
Mirum Pharmaceuticals reported financial results for 2022, marking a successful first full year for LIVMARLI® with net product sales of $75.1 million. Total revenue reached $77.1 million, a significant increase from $3.1 million in 2021. The company anticipates a 50% year-over-year growth in net sales for 2023, fueled by recent launches in Germany and potential label expansions. The fourth quarter saw a 48% sales increase over Q3 2022. Strong data from the Phase 3 MARCH-PFIC study highlights LIVMARLI's efficacy in treating pruritus and serum bile acids. Mirum has raised $121.9 million in capital since January 2022, strengthening its balance sheet.
Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) will announce its fourth quarter and year-end 2022 financial results on March 8, 2023, at 4:30 p.m. ET. The company will host a conference call to discuss these results along with recent corporate developments. Participants can join the conference call by dialing 1 833 927 1758 in the U.S. or 1 929 526 1599 internationally, with the passcode 596100. The call will also be available via webcast on Mirum's website for 30 days post-event. Mirum focuses on treatments for rare liver diseases, including its approved medication LIVMARLI®.
Mirum Pharmaceuticals has submitted a supplemental New Drug Application (sNDA) for LIVMARLI (maralixibat) to treat cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) aged two months and older. This submission is based on significant findings from the MARCH Phase 3 study, which involved 93 patients and demonstrated high statistical significance (p<0.0001) in reducing itch severity. If approved, LIVMARLI will also treat cholestatic pruritus in Alagille syndrome (ALGS). Currently, LIVMARLI is already approved for ALGS in the U.S., Israel, and the European Union.
On February 10, 2023, Mirum Pharmaceuticals (NASDAQ: MIRM) granted inducement awards to a new employee, which included non-qualified stock options for 5,000 shares and 2,500 restricted stock units (RSUs). The stock options have an exercise price of $23.67, equal to the closing price on the grant date, and will vest over four years. The RSUs will vest over three years. These awards are part of Mirum’s 2020 Inducement Plan, adhering to Nasdaq Listing Rule 5635(c)(4). Mirum is focused on rare liver diseases with an approved treatment, LIVMARLI, and ongoing clinical trials for additional treatments.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical firm specializing in treatments for rare liver diseases, will present at the SVB Securities Global Biopharma Conference on February 15, at 5:00 p.m. ET. The company’s approved drug, LIVMARLI® (maralixibat), is used to treat cholestatic pruritus in patients with Alagille syndrome. Mirum’s pipeline includes two investigational treatments, with LIVMARLI undergoing trials for pediatric liver diseases and volixibat being studied for primary sclerosing cholangitis and primary biliary cholangitis. For further information, visit Mirum's corporate website.
Mirum Pharmaceuticals (MIRM) anticipates a strong financial performance for 2022, projecting $76 million in total revenue, with $74 million stemming from LIVMARLI net product sales. The company plans to submit a supplemental NDA for LIVMARLI targeting PFIC in Q1 2023, alongside various data analyses for its late-stage cholestasis programs. As of December 31, 2022, Mirum reported approximately $252 million in cash and equivalents. Additionally, the CFO, Dr. Ian Clements, will depart in May 2023, marking a leadership transition.
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.