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 has received FDA approval for LIVMARLI™ (maralixibat), the first medication for treating cholestatic pruritus in patients with Alagille syndrome aged one year and older. This rare liver disease affects approximately 2,000 to 2,500 children in the U.S. LIVMARLI is an oral solution that targets the underlying cause of debilitating itch associated with this condition. The approval is based on the pivotal ICONIC study showing significant symptom reduction. Mirum also received a rare pediatric disease priority review voucher.
Mirum Pharmaceuticals has entered into an exclusive licensing agreement with Takeda Pharmaceutical Company for the development and commercialization of maralixibat in Japan. This investigational drug targets rare liver diseases such as Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia. Takeda will oversee regulatory approval and conduct clinical studies. Mirum has also submitted a new drug application for maralixibat in the U.S., with a priority review by the FDA expected by September 29, 2021.
Mirum Pharmaceuticals has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for treating cholestatic liver disease in Alagille syndrome (ALGS). This marks a significant advancement as it could introduce the first pharmacologic treatment for this rare disease. The MAA includes positive results from the ICONIC study, indicating marked improvements in survival and liver health metrics. Furthermore, Mirum plans to resubmit its MAA for progressive familial intrahepatic cholestasis (PFIC) after the MARCH-PFIC Phase 3 study results are available.
On September 10, 2021, Mirum Pharmaceuticals (Nasdaq: MIRM) announced the grant of non-qualified stock option awards for 87,500 shares to ten new employees as part of its 2020 Inducement Plan. The options have an exercise price of $18.21 and will vest over four years. Mirum's lead product, maralixibat, is under FDA priority review for cholestatic pruritus in Alagille syndrome, with a PDUFA date of September 29, 2021. The company is also developing gene therapies for PFIC2 and PFIC3, enhancing its pipeline in liver diseases.
Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced its participation in five investor conferences during September 2021. Key events include the Citi 16th Annual BioPharma Virtual Conference on September 10, and the H.C. Wainwright Global Investor Conference from September 13-14, featuring a company presentation. Additional conferences include the Baird Global Healthcare Conference, the Leerink CyberRX Series 1x1 Event, and the Cantor Global Healthcare Conference. Mirum focuses on innovative therapies for liver diseases, with its lead candidate, maralixibat, under FDA priority review.
Mirum Pharmaceuticals has appointed William C. Fairey to its Board of Directors, bringing nearly 30 years of experience in global commercial strategy, particularly in rare diseases. His appointment coincides with the resignation of Tiba Aynechi, effective August 19, 2021. Fairey’s role will be vital as Mirum prepares for the U.S. launch of its first medication and advances its pipeline of therapies for rare liver diseases. The company’s lead candidate, maralixibat, is under priority review by the FDA, with a decision expected by September 29, 2021.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced on August 10, 2021, that it granted non-qualified stock option awards for 95,200 shares to eight new employees as an inducement under its 2020 Inducement Plan. The options have an exercise price of $14.05 per share, reflecting the closing price on the grant date, and will vest over four years. Furthermore, the company is advancing its pipeline, including maralixibat, which is under priority review for treating cholestatic pruritus, with a PDUFA date of September 29, 2021. Mirum also acquired options for two gene therapy programs from Vivet Therapeutics.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced its financial results for Q2 2021, reporting a net loss of $43.9 million, or $1.45 per share, compared to a loss of $23.3 million in Q2 2020. Licensing revenue rose to $11.0 million, reflected in a collaboration with CANbridge Pharmaceuticals. Total operating expenses surged to $48.4 million, influenced by increased research and development costs. Looking ahead, the FDA has set a PDUFA date of September 29, 2021, for maralixibat, with a commercial opportunity exceeding $500 million. The company is advancing its clinical pipeline with multiple expected data releases in 2022.
Mirum Pharmaceuticals (Nasdaq: MIRM) will announce its financial results for Q2 2021 on August 5, 2021, at 1:30 p.m. PT/4:30 p.m. ET, followed by a conference call for business updates. The lead product, maralixibat, targets debilitating liver diseases and has a New Drug Application (NDA) under priority review by the FDA, with a PDUFA date of September 29, 2021. Additionally, Mirum is expanding its portfolio through exclusive options for gene therapy programs aimed at treating PFIC3 and PFIC2.
Mirum Pharmaceuticals has entered into an exclusive licensing agreement with GC Pharma for the development and commercialization of maralixibat in South Korea. Maralixibat is under investigation for treating Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia. Mirum will receive an upfront payment of $5 million along with potential milestone payments and tiered royalties based on net sales. The FDA has accepted a New Drug Application for maralixibat for cholestatic pruritus with a review due by September 29, 2021.
FAQ
What is the current stock price of Mirum Pharmaceuticals (MIRM)?
What is the market cap of Mirum Pharmaceuticals (MIRM)?
