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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 announced the submission of its rolling New Drug Application (NDA) for maralixibat to the FDA, targeting cholestatic pruritus in patients with Alagille syndrome (ALGS) aged one year and older. ALGS is a rare liver disease without approved therapies. The NDA includes data from the ICONIC study, involving 86 patients and six-year follow-up. A U.S. launch is anticipated in late 2021, pending approval.
Mirum Pharmaceuticals has initiated patient enrollment in its Phase 2b VISTAS study for volixibat, targeting adult patients with primary sclerosing cholangitis (PSC). This chronic liver disease lacks approved therapies and is characterized by bile duct inflammation. The study will assess the efficacy of volixibat in reducing pruritus and include secondary endpoints like safety and quality of life measures over 28 weeks. Approximately 29,000 people in the U.S. suffer from PSC, underscoring the need for effective treatments.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) provided a corporate update ahead of the J.P. Morgan Healthcare Conference, highlighting significant 2021 developments. The company expects to complete its rolling NDA submission for maralixibat for Alagille syndrome by Q1 2021, while three clinical studies for maralixibat and volixibat are set to begin. With $231.8 million in cash and investments, including proceeds from recent financings, Mirum is financially equipped for growth and launch readiness. The company also appointed Alexey Kutahov, MD, to lead its European launch activities.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced that its Board of Directors granted stock options to five new employees, totaling 49,900 shares, under the 2020 Inducement Plan. The options have an exercise price of $19.81, reflecting the closing stock price on January 8, 2021. Vesting occurs over four years, with 25% vesting after one year. Mirum is focused on developing therapies for liver diseases, and its lead candidate, maralixibat, is under NDA submission for Alagille syndrome treatment. The company’s application for pediatric PFIC2 treatment is under review by the European Medicines Agency.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced its participation in the J.P. Morgan Healthcare Conference, set for January 11-14, 2021. CEO Chris Peetz will discuss Mirum’s strategy and commercialization plans for maralixibat and volixibat during a presentation on January 12, from 5:20 to 6:00 p.m. ET. A live audio webcast will be accessible on the company's website. Mirum is advancing its drug pipeline for liver diseases, with maralixibat's NDA submission expected in Q1 2021 and EMA review for pediatric PFIC2 treatment underway.
Mirum Pharmaceuticals has priced its underwritten public offering of 3,750,000 common stock shares at $20.00 each, aiming to raise $75 million. A 30-day option allows underwriters to acquire an additional 562,500 shares. The offering, expected to close on December 17, 2020, will utilize proceeds for developing novel therapies targeting liver diseases. Regulatory submissions for key products like maralixibat are ongoing, with potential impacts on future market performance.
Mirum Pharmaceuticals has announced a public offering to sell $75 million in common stock, with a potential additional $11.3 million available for underwriters. The offering will be executed under a previously declared effective shelf registration statement. Leading this initiative are J.P. Morgan, SVB Leerink, and Evercore ISI as joint book-running managers. Mirum is focused on novel therapies for liver diseases, with key products like maralixibat for conditions such as Alagille syndrome and PFIC. Completion of the offering is subject to market conditions.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) has granted a stock option award of 11,300 shares to a new employee under its 2020 Inducement Plan. The options have an exercise price of $24.93 per share, vesting over four years with the first 25% on the one-year anniversary. Mirum focuses on novel therapies for liver diseases, with its lead candidate, maralixibat, in late-stage development for multiple conditions. The company is advancing a rolling NDA submission for maralixibat and has an application for PFIC2 under review by the European Medicines Agency.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced a $200 million tiered, revenue-based funding agreement with Oberland Capital, inclusive of a $10 million equity investment. Milestones include $60 million by year-end 2020, $65 million upon FDA NDA acceptance for maralixibat in treating ALGS, and $35 million upon FDA approval. Mirum is advancing its rolling NDA submission for maralixibat and expects to launch in the U.S. in H2 2021. Additionally, it has submitted a marketing application to the EMA for PFIC2 treatment, validating its strategic pipeline development for rare liver diseases.
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