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 (MIRM) delivers innovative therapies for rare liver diseases through targeted IBAT inhibitor development. This page provides centralized access to official announcements, clinical trial updates, and strategic developments from the biopharmaceutical innovator.
Investors and healthcare professionals will find timely updates on regulatory milestones, partnership agreements, and pipeline advancements. Our curated feed includes verified press releases about Maralixibat approvals, Volixibat trial progress, and corporate initiatives addressing conditions like progressive familial intrahepatic cholestasis.
Key updates cover FDA communications, research collaborations, and commercialization strategies for orphan drug therapies. All content is sourced directly from Mirum’s disclosures to ensure accuracy and compliance with financial reporting standards.
Bookmark this page for streamlined access to Mirum’s latest advancements in minimally absorbed liver disease treatments. Check regularly for critical updates impacting clinical development timelines and therapeutic availability.
Mirum Pharmaceuticals has submitted a variation application to the European Medicines Agency (EMA) to extend the Marketing Authorization for LIVMARLI (maralixibat) to treat progressive familial intrahepatic cholestasis (PFIC) in patients aged two months and older. This is based on data from the Phase 3 MARCH study, the largest trial for PFIC, showing significant improvements in serum bile acids, pruritus, bilirubin, and growth metrics. LIVMARLI is already approved for treating cholestatic pruritus associated with Alagille syndrome. The company also submitted a supplemental application to the U.S. FDA for similar use in PFIC patients three months and older.
Mirum Pharmaceuticals announced that the FDA has approved a label expansion for LIVMARLI® (maralixibat), lowering the age requirement for treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) from one year to three months. This change is supported by data from the RISE study on the safety and tolerability of LIVMARLI in infants. The approval allows early treatment for the majority of ALGS patients diagnosed before one year. Currently, LIVMARLI is also approved in Europe for patients aged two months and older. Mirum has also submitted a supplemental NDA for treating cholestatic pruritus in progressive familial intrahepatic cholestasis.
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
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.
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