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 (Nasdaq: MIRM) announced the granting of non-qualified stock options to three new employees, totaling 21,500 shares. These options, priced at $21.22 each, are part of the 2020 Inducement Plan and will vest over four years. The decision aligns with Nasdaq Listing Rule 5635(c)(4). Mirum focuses on developing therapies for liver diseases, with its lead candidate, maralixibat, under NDA review for Alagille syndrome and a marketing application for PFIC accepted by the European Medicines Agency.
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.
