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 (MIRM) recently presented findings from its clinical programs for maralixibat and volixibat at the Annual Meeting of the American Association for the Study of Liver Diseases. Maralixibat, an investigational therapy for Alagille syndrome, demonstrated significant correlations between pruritus intensity and cholestasis biomarkers in pediatric patients, emphasizing its potential benefits. The company is excited to initiate Phase 2 studies of volixibat, aimed at evaluating its efficacy in adult patients with cholestatic liver diseases. These developments may impact both clinical outcomes and market positioning for MIRM.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced its financial results for Q3 2020, reporting a net loss of $21.5 million, or $0.86 per share, compared to a loss of $15.1 million, or $0.84 per share in Q3 2019. Total operating expenses rose to $21.7 million, driven by R&D costs of $16.0 million. The company is making strides in treating liver diseases, with a rolling NDA submission for maralixibat, and plans to launch it for Alagille syndrome.
Mirum also initiated an Expanded Access Program and received FDA Orphan Drug and Rare Pediatric Disease designations for maralixibat.
On November 10, 2020, Mirum Pharmaceuticals granted stock options for 36,300 shares to two new employees under its 2020 Inducement Plan. The exercise price is fixed at $17.96, based on the closing stock price on that date. The options will vest over four years, with 25% vesting after one year and the remainder vesting monthly thereafter. Mirum is focused on developing therapies for liver diseases, notably maralixibat, which is in the process of NDA submission for Alagille syndrome and plans for a marketing application for PFIC2.
Mirum Pharmaceuticals (Nasdaq: MIRM) has expanded its Expanded Access Program (EAP) for maralixibat, targeting cholestatic pruritus in Alagille syndrome (ALGS), to Australia and several European countries. This follows the EAP's initiation in the U.S. and Canada. Maralixibat, an investigational drug, aims to help patients manage severe symptoms associated with ALGS until regulatory approval. The EAP is now available to eligible patients in multiple countries, enhancing access to this promising therapy for a rare genetic disorder characterized by liver dysfunction.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced the presentation of new data from maralixibat and volixibat studies at The Liver Meeting 2020, hosted by the AASLD from November 13-16. Key presentations include a late-breaker oral presentation on maralixibat's long-term effects in children with Alagille syndrome and several poster presentations discussing volixibat's impact on fecal bile acid excretion. Maralixibat aims to mitigate liver damage in rare cholestatic diseases, having been administered to over 1,600 individuals, showing promise for future FDA approvals.
Mirum Pharmaceuticals (Nasdaq: MIRM) recently announced that data from its maralixibat studies will be presented at the NASPGHAN Annual Meeting 2020 (November 1-7). Key presentations include long-term safety and efficacy data for maralixibat in children with Alagille syndrome and findings on genotype responses in patients with bile salt export pump deficiency. Mirum will also sponsor a symposium addressing pediatric cholestasis. The FDA has granted Breakthrough Therapy designation for maralixibat aimed at treating pruritus associated with Alagille syndrome.
Mirum Pharmaceuticals has partnered with EVERSANA to lead the U.S. market access, distribution, and patient services for maralixibat, an investigational treatment for cholestatic pruritus in patients with Alagille syndrome. Following the initiation of its rolling NDA in August 2020, Mirum anticipates completing the submission in early 2021 and plans to launch the drug in the second half of 2021. Maralixibat aims to alleviate severe symptoms associated with rare liver diseases, with current studies showing positive safety profiles and efficacy indicators.
Mirum Pharmaceuticals (MIRM) has partnered with EVERSANA to manage market access, distribution, and patient services for its investigational drug, maralixibat, aimed at treating cholestatic pruritus in Alagille syndrome (ALGS). Mirum plans to complete its New Drug Application (NDA) submission to the FDA in Q1 2021 and prepare for a potential launch in H2 2021. Maralixibat has received Breakthrough Therapy designation and has shown promising results in clinical trials, demonstrating significant reductions in bile acids and associated symptoms.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced on October 9, 2020, the granting of non-qualified stock options to purchase 74,100 shares to seven new employees under its 2020 Inducement Plan. Each option has an exercise price of $19.84, vesting over four years. The company is focused on developing therapies for liver diseases, including its lead candidate, maralixibat, targeting conditions like Alagille syndrome and progressive familial intrahepatic cholestasis. Mirum plans to submit marketing applications for maralixibat in the U.S. and Europe by early 2021.