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. (NASDAQ: MIRM) is a biopharmaceutical and rare disease company with approved and investigational therapies targeting rare liver and neurodevelopmental conditions. The Mirum news feed on Stock Titan aggregates company announcements, press releases and corporate disclosures so readers can follow how its commercial portfolio and pipeline evolve over time.
Investors and followers of MIRM can review news about LIVMARLI (maralixibat), CHOLBAM (cholic acid) and CTEXLI (chenodiol), including regulatory updates, commercial milestones and clinical study developments. Coverage also includes updates on clinical-stage programs such as volixibat for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), brelovitug for chronic hepatitis delta virus (HDV) in connection with the proposed Bluejay Therapeutics acquisition, and MRM-3379 for Fragile X syndrome (FXS).
News items commonly highlight Mirum’s participation in healthcare and investor conferences, private placement financings, inducement equity grants under Nasdaq Listing Rule 5635(c)(4), and material events reported via Form 8-K filings. Company press releases also discuss regulatory designations, study initiations, enrollment updates and planned timelines for key clinical readouts, as described in Mirum’s own communications.
This page offers a centralized view of Mirum-related headlines, allowing readers to track commercial performance commentary, pipeline progress and transaction announcements in one place. For users researching MIRM stock or the company’s rare disease programs, the news feed provides direct access to the narrative Mirum shares with the market.
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.
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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.