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. (symbol: MIRM) is a biopharmaceutical company headquartered in Foster City, California. Established in 2018, the company focuses on the development and commercialization of innovative therapies aimed at treating debilitating liver diseases. Mirum Pharmaceuticals is dedicated to addressing rare and orphan diseases, making significant strides in this niche sector of the healthcare market.
At the core of Mirum Pharmaceuticals' product pipeline is Maralixibat, an investigational oral drug currently in phase 3 clinical trials. Maralixibat is being studied for its efficacy in treating several severe liver conditions, including Progressive Familial Intrahepatic Cholestasis (PFIC), Alagille Syndrome (ALGS), and Biliary Atresia. This product represents a potential breakthrough in providing therapeutic options for these challenging conditions.
In addition, the company has developed Volixibat, a drug aimed at treating Intrahepatic Cholestasis of Pregnancy (ICP) and Primary Sclerosing Cholangitis (PSC). These ongoing projects highlight Mirum Pharmaceuticals' commitment to advancing the treatment landscape for liver diseases with significant unmet medical needs.
Mirum Pharmaceuticals has achieved notable milestones, such as the approval of Livmarli, an orally administered, minimally-absorbed ileal bile acid transporter (IBAT) inhibitor. Livmarli is approved for the treatment of cholestatic pruritus in patients with Alagille Syndrome (ALGS), providing much-needed relief for those affected by this condition.
The company stands out for its strategic approach to identifying, acquiring, and developing novel therapies. It has established partnerships and collaborations to bolster its research endeavors and expand its reach in the biopharmaceutical industry. With a robust pipeline and a clear focus on debilitating liver diseases, Mirum Pharmaceuticals continues to make significant progress in its mission to improve patient outcomes and quality of life.
For the latest news and updates about Mirum Pharmaceuticals, including recent achievements, ongoing projects, and financial performance, investors and stakeholders can rely on resources like StockTitan for comprehensive and timely information.
Stay informed about Mirum Pharmaceuticals, Inc. and its groundbreaking work in the biopharmaceutical sector, and keep track of the latest developments and stock performance on StockTitan.
Mirum Pharmaceuticals has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for LIVMARLI® (maralixibat) oral solution for treating Progressive Familial Intrahepatic Cholestasis (PFIC) in patients aged three months and older. This decision is based on the Phase 3 MARCH study, which showed a highly significant reduction in pruritus severity (p<0.0001) compared to placebo across all PFIC types. Furthermore, the Committee for Orphan Medicinal Products (COMP) recommended maintaining the Orphan Drug Designation for LIVMARLI in PFIC. A final decision by the European Commission is expected in Q3 2024. Currently, LIVMARLI is approved for treating cholestatic pruritus in Alagille syndrome (ALGS) in Europe and the U.S., and for PFIC in U.S. patients aged five years and older. Mirum also plans to submit a supplemental new drug application (sNDA) to expand the label for younger PFIC patients in the U.S.
Mirum Pharmaceuticals announced the presentation of new long-term data from LIVMARLI studies at the upcoming EASL Annual Congress in Milan, Italy (June 5-8, 2024). The data highlights sustained clinical benefits of LIVMARLI for Alagille syndrome (ALGS) over seven years and improvements in liver markers and growth for Progressive Familial Intrahepatic Cholestasis (PFIC) patients. Key presentations include:
- THU-094: Clinical benefits of Maralixibat for ALGS patients through 7 years (MERGE Study).
- THU-129: Maralixibat improves growth in PFIC patients (MARCH/MARCH-ON Trials).
- THU-158: Serum bile acid levels and liver health improvements in PFIC children after Maralixibat treatment (MARCH/MARCH-ON Trials).
Additionally, a Mirum-sponsored symposium will discuss the role of IBAT inhibitors in adult hepatology and unmet needs in primary sclerosing cholangitis (PSC).
Mirum Pharmaceuticals presented data on their oral solution, LIVMARLI (maralixibat), at the 56th ESPGHAN Annual Meeting in Milan. Seven abstracts highlighted LIVMARLI's efficacy in treating Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). Key findings from the Phase 3 MARCH-ON PFIC study showed significant and sustained improvements in pruritus severity, serum bile acid levels, total bilirubin, and growth over two years. One-third of patients on LIVMARLI discontinued at least one antipruritic medication. These results underscore LIVMARLI's potential in improving liver health and reducing medication dependency in children with PFIC and ALGS.
Mirum Pharmaceuticals, Inc. announced the granting of inducement awards to new employees under the 2020 Inducement Plan. The grants consist of stock options and restricted stock units (RSUs) totaling 38,600 shares of common stock and 19,300 RSUs. The stock options have an exercise price of $24.76 per share, will vest over four years, and the RSUs will vest over three years. The awards were approved by the Compensation Committee of Mirum's Board of Directors as an inducement material for the new employees' employment.
Mirum Pharmaceuticals reported a strong first quarter in 2024, with total revenue of $69.2 million and on track to achieve full-year guidance of $310 to $320 million. The FDA approval of LIVMARLI for cholestatic pruritus in PFIC patients was achieved in March. The company maintains a cash balance of $302.8 million as of March 31, 2024, and has important interim analyses scheduled for June 2024. Mirum's commercial business is performing well, with continued demand growth and net sales increase.
Mirum Pharmaceuticals, a biopharmaceutical company specializing in rare and orphan diseases, is set to present at the Citizens JMP Life Sciences Conference in New York on May 14th. Investors can access the webcast via Mirum's website.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced the publication of Phase 3 MARCH data in The Lancet, showcasing the benefits of LIVMARLI (maralixibat) in patients with PFIC. The study confirmed the efficacy and safety of LIVMARLI across a broad genetic range of PFIC types, with significant improvements observed in pruritus, serum bile acids, growth, and bilirubin levels.
Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) will announce its first quarter 2024 financial results on May 8, 2024, followed by a conference call to discuss recent corporate progress. The call will be accessible via phone or webcast.
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