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. (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 (NASDAQ: MIRM) reported strong financial results for Q4 and full-year 2024, with total net product sales reaching $336.4 million, up from $178.9 million in 2023. The company provided guidance for 2025, expecting global net product sales of $420-435 million.
LIVMARLI sales contributed $213.3 million in 2024, while Bile Acid Medicines generated $123.1 million. The global LIVMARLI business expanded to 30 countries, including successful launches in major European markets.
Key pipeline developments include expected completion of the VISTAS study enrollment for volixibat in PSC during H2 2025, with topline data in 2026. The company reported $292.8 million in cash and investments as of December 31, 2024, compared to $286.3 million at the end of 2023.
Mirum Pharmaceuticals (NASDAQ: MIRM) has received FDA approval for CTEXLI™ (chenodiol) tablets, becoming the first and only approved treatment for adults with cerebrotendinous xanthomatosis (CTX), a rare and progressive disease. The approval is based on the Phase 3 RESTORE study results, which demonstrated highly significant reduction in bile alcohols (p<0.0001) with a 20-fold difference between placebo and CTEXLI-treated patients.
The study showed CTEXLI improved both urine bile alcohol and serum cholestanol levels. In CTX patients, a deficiency of bile acid chenodeoxycholic acid leads to toxic accumulation of cholestanol, causing irreversible neurologic dysfunction. The drug has been granted FDA Orphan Drug exclusivity and will be available through Mirum Access Plus (MAP), the company's patient support program.
Mirum Pharmaceuticals (NASDAQ: MIRM) has scheduled its fourth quarter and year-end 2024 financial results announcement for Wednesday, February 26, 2025. The company will host a conference call at 4:30 p.m. ET / 1:30 p.m. PT on the same day to discuss the financial results and recent corporate progress.
Investors can access the call via U.S./Toll-Free number +1 833 470 1428 or International number +1 404 975 4839 using passcode 126145. A webcast option is also available through the Events & Presentations section on Mirum's website, with a replay accessible for 30 days.
Mirum Pharmaceuticals (MIRM) has announced inducement grants approved by its Compensation Committee for 10 new employees. The grants include non-qualified stock options to purchase 49,600 shares of common stock at $50.46 per share and 24,800 restricted stock units (RSUs).
The stock options will vest over four years, with 25% vesting after one year and the remaining vesting monthly over 36 months. The RSUs will vest over three years, with 33% vesting annually. Both grants are subject to continued employment with Mirum and were awarded under the company's 2020 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
Mirum Pharmaceuticals (NASDAQ: MIRM) reported preliminary unaudited 2024 net product sales of approximately $336 million, exceeding their guidance. The company projects 2025 global net product sales between $420-435 million. LIVMARLI contributed approximately $213 million in 2024 sales, while CHOLBAM and CHENODAL generated approximately $123 million.
Key 2024 achievements include FDA approval for LIVMARLI in PFIC patients, positive interim results for volixibat in PSC and PBC studies, and expansion to 30 countries with commercial access. The company maintained financial strength with approximately $287 million in cash and investments as of December 31, 2024, achieving positive cash flow from operations in Q3 2024.
Looking ahead, Mirum expects to complete enrollment for the VISTAS study in PSC in second half 2025, with topline data in 2026. The FDA PDUFA date for chenodiol in CTX is set for March 28, 2025.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced inducement awards granted by its Compensation Committee to eight new employees on January 10, 2025. The awards, approved under Nasdaq Listing Rule 5635(c)(4), include:
- Non-qualified stock options to purchase 53,900 shares of common stock at $41.32 per share (closing price on January 10, 2025)
- 26,950 restricted stock units (RSUs)
The stock options will vest over four years, with 25% vesting after one year and the remainder monthly over 36 months. The RSUs will vest over three years, with 33% vesting annually, subject to continued employment. These grants were made under Mirum's 2020 Inducement Plan.
Mirum Pharmaceuticals (Nasdaq: MIRM) has announced its upcoming presentation at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation is scheduled for Wednesday, January 15, 2025, at 9:45 a.m. PT.
The event will include both a presentation and a question-and-answer session, which will be accessible via webcast. Interested parties can access the live webcast through the Investors and Media section of Mirum's corporate website. A replay of the webcast will remain available for 30 days following the presentation.
Mirum Pharmaceuticals specializes in identifying, acquiring, developing, and commercializing novel therapies for debilitating rare and orphan diseases.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced inducement grants approved by its Compensation Committee on December 10, 2024. The grants include 48,400 non-qualified stock options and 24,200 restricted stock units (RSUs) awarded to five new employees under the company's 2020 Inducement Plan.
The stock options, priced at $44.10 per share, will vest over four years with 25% vesting after one year and the remainder monthly over 36 months. The RSUs will vest over three years, with 33% vesting annually, subject to continued employment. These grants were made in accordance with Nasdaq Listing Rule 5635(c)(4).
Mirum Pharmaceuticals (NASDAQ: MIRM) announced its participation at AASLD's The Liver Meeting, scheduled for November 15-19, 2024, in San Diego. The company will present multiple clinical studies including the VANTAGE trial studying volixibat for primary biliary cholangitis, MARCH-ON trial data on Progressive Familial Intrahepatic Cholestasis, and research on LIVMARLI (maralixibat). Presentations will cover various aspects including pruritus improvements, caregiver burden, real-world usage in biliary atresia, and bile acid correlations. The event will also feature a fireside discussion with a physician and an ALGS patient sharing experience with LIVMARLI.
Mirum Pharmaceuticals (Nasdaq: MIRM) reported third-quarter 2024 financial results, showcasing a significant growth in net product sales, reaching $90.3 million, an 89% increase compared to Q3 2023. The company has raised its 2024 guidance to $330 - 335 million. Key developments include the breakthrough therapy designation for volixibat in PBC, with interim results to be presented at the AASLD Liver Meeting 2024. The PDUFA date for chenodiol in CTX is set for December 28, 2024. Mirum also in-licensed global rights to the PDE4D inhibitor MRM-3379, targeting Fragile X syndrome, with a Phase 2 study initiation expected in 2025. As of September 30, 2024, Mirum's cash, cash equivalents, and investments totaled $293.8 million. Operating expenses for Q3 2024 were $103.1 million, up from $72.9 million in Q3 2023. A business update conference call is scheduled for November 12, 2024.
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