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Mirum Pharmaceuticals, Inc. - MIRM STOCK NEWS

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.

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Mirum Pharmaceuticals (Nasdaq: MIRM) announced inducement grants on July 10, 2024, under Nasdaq Listing Rule 5635(c)(4). The grants include non-qualified stock options for 40,800 shares of common stock and 20,400 restricted stock units (RSUs) to seven new employees. The stock options have an exercise price of $35.92 per share, based on Mirum's closing trading price on July 10, 2024. These options will vest over four years, starting with 25% on the one-year anniversary and the remaining vesting monthly over the next 36 months. The RSUs will vest over three years, with 33% vesting each year, contingent upon the employees' continued service. The grants fall under Mirum's 2020 Inducement Plan and are aligned with applicable award agreements.

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The European Commission has granted marketing authorization for Mirum Pharmaceuticals' LIVMARLI (maralixibat) oral solution to treat progressive familial intrahepatic cholestasis (PFIC) in patients aged three months and older. This approval follows the positive opinion from the CHMP, noting LIVMARLI's significant clinical benefits over existing PFIC treatments. The decision also aligns with a positive COMP opinion recommending the continuation of Orphan Drug Designation for LIVMARLI in PFIC. Approval is based on data from the Phase 3 MARCH study, the largest randomized trial in PFIC, showing substantial reductions in pruritus and serum bile acids with LIVMARLI compared to placebo. The study included 93 patients with various genetic types of PFIC. Common adverse events were mild and transient diarrhea. LIVMARLI is also approved in the U.S. for treating cholestatic pruritus in PFIC patients aged five years and older.

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Mirum Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for chenodiol, aiming to treat cerebrotendinous xanthomatosis (CTX), a rare genetic disorder of cholesterol metabolism. The submission is based on positive results from the Phase 3 RESTORE study, which showed a significant reduction in bile alcohols and improved serum cholestanol in patients treated with chenodiol. The study's primary endpoint was met with high statistical significance (p<0.0001), and chenodiol demonstrated a 20-fold difference in efficacy compared to placebo. Diarrhea and headache were the most common adverse events, generally mild or moderate. If approved, chenodiol would be the first and only therapy available in the US for CTX, offering hope for early diagnosis and treatment of this debilitating condition.

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Mirum Pharmaceuticals (Nasdaq: MIRM) announced positive interim results from two Phase 2b studies evaluating volixibat in patients with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC).

In the VANTAGE PBC study, volixibat demonstrated a statistically significant improvement in pruritus with a 3.82 point reduction (p<0.0001) and a 2.32 point placebo-adjusted difference (p=0.0026). 75% of patients on volixibat achieved over 50% reduction in serum bile acids. Fatigue also improved significantly at week 16, with no new safety signals. The most common adverse event was mild to moderate diarrhea (77%).

The VISTAS PSC study exceeded the efficacy threshold for continuation. The independent data review committee recommended continuing the study with the current dose of 20 mg twice daily. Mirum will discuss these findings in a conference call on June 17 at 8:30 a.m. ET.

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Mirum Pharmaceuticals (NASDAQ: MIRM) will host an investor call on June 17, 2024, at 8:30 a.m. ET to present interim results from two Phase 2b studies: the Volixibat VANTAGE study for primary biliary cholangitis (PBC) and the Volixibat VISTAS study for primary sclerosing cholangitis (PSC). Dial-in options are available, and a webcast will be accessible on Mirum's website. The replay of the call will be available for 30 days.

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Mirum Pharmaceuticals (NASDAQ: MIRM) has announced the grant of inducement awards to 14 new employees under its 2020 Inducement Plan. On June 10, 2024, the Compensation Committee of Mirum’s Board of Directors approved stock options for 56,600 shares and 28,300 restricted stock units (RSUs). The stock options have an exercise price of $25.55 per share and will vest over four years, with 25% vesting after one year and the remainder vesting monthly over the next three years. The RSUs will vest over three years, with 33% vesting annually. These awards are in accordance with Nasdaq Listing Rule 5635(c)(4).

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Mirum Pharmaceuticals presented data at the EASL Congress showing long-term benefits of LIVMARLI (maralixibat) in treating Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). The MERGE study demonstrated sustained clinical benefits for ALGS patients over seven years, including reductions in pruritus and serum bile acids, and improvements in height.

The MARCH/MARCH-ON trials indicated statistically significant growth improvements in PFIC patients over 82 weeks, with better height and weight z-scores. Another analysis from these trials showed that reductions in serum bile acids correlated with improved liver health markers like bilirubin, suggesting potential disease-modifying effects of LIVMARLI.

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Mirum Pharmaceuticals (Nasdaq: MIRM) announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference in Miami on June 12th at 10:00 AM EDT.

The company, known for developing therapies for rare and orphan diseases, will provide a presentation accessible via the Investors and Media section on Mirum's corporate website.

For more details, investors can visit the company's site for webcast links and additional information.

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Mirum Pharmaceuticals has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) for LIVMARLI® (maralixibat) oral solution for treating Progressive Familial Intrahepatic Cholestasis (PFIC) in patients aged three months and older. This decision is based on the Phase 3 MARCH study, which showed a highly significant reduction in pruritus severity (p<0.0001) compared to placebo across all PFIC types. Furthermore, the Committee for Orphan Medicinal Products (COMP) recommended maintaining the Orphan Drug Designation for LIVMARLI in PFIC. A final decision by the European Commission is expected in Q3 2024. Currently, LIVMARLI is approved for treating cholestatic pruritus in Alagille syndrome (ALGS) in Europe and the U.S., and for PFIC in U.S. patients aged five years and older. Mirum also plans to submit a supplemental new drug application (sNDA) to expand the label for younger PFIC patients in the U.S.

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Mirum Pharmaceuticals announced the presentation of new long-term data from LIVMARLI studies at the upcoming EASL Annual Congress in Milan, Italy (June 5-8, 2024). The data highlights sustained clinical benefits of LIVMARLI for Alagille syndrome (ALGS) over seven years and improvements in liver markers and growth for Progressive Familial Intrahepatic Cholestasis (PFIC) patients. Key presentations include:

- THU-094: Clinical benefits of Maralixibat for ALGS patients through 7 years (MERGE Study).

- THU-129: Maralixibat improves growth in PFIC patients (MARCH/MARCH-ON Trials).

- THU-158: Serum bile acid levels and liver health improvements in PFIC children after Maralixibat treatment (MARCH/MARCH-ON Trials).

Additionally, a Mirum-sponsored symposium will discuss the role of IBAT inhibitors in adult hepatology and unmet needs in primary sclerosing cholangitis (PSC).

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FAQ

What is the focus of Mirum Pharmaceuticals, Inc.?

Mirum Pharmaceuticals focuses on developing and commercializing therapies for debilitating liver diseases, particularly rare and orphan conditions.

What is Maralixibat used for?

Maralixibat is an investigational oral drug for treating Progressive Familial Intrahepatic Cholestasis (PFIC), Alagille Syndrome (ALGS), and Biliary Atresia.

Where is Mirum Pharmaceuticals headquartered?

Mirum Pharmaceuticals is headquartered in Foster City, California.

What is Livmarli?

Livmarli is an orally administered, minimally-absorbed ileal bile acid transporter (IBAT) inhibitor approved for treating cholestatic pruritus in patients with Alagille Syndrome (ALGS).

When was Mirum Pharmaceuticals founded?

Mirum Pharmaceuticals was founded in 2018.

What is Volixibat being developed for?

Volixibat is being developed to treat Intrahepatic Cholestasis of Pregnancy (ICP) and Primary Sclerosing Cholangitis (PSC).

What are the recent achievements of Mirum Pharmaceuticals?

Recent achievements include the approval of Livmarli for treating cholestatic pruritus in ALGS patients and ongoing phase 3 trials for Maralixibat.

How does Mirum Pharmaceuticals contribute to the biopharmaceutical industry?

Mirum Pharmaceuticals contributes by developing novel therapies for rare liver diseases and establishing strategic partnerships to advance research.

How can I get the latest updates on Mirum Pharmaceuticals?

You can stay informed about the latest updates and stock performance of Mirum Pharmaceuticals on platforms like StockTitan.

What products are in Mirum Pharmaceuticals' pipeline?

Products in the pipeline include Maralixibat for PFIC and ALGS and Volixibat for ICP and PSC.

Mirum Pharmaceuticals, Inc.

Nasdaq:MIRM

MIRM Rankings

MIRM Stock Data

1.86B
47.13M
2.23%
118.74%
16.55%
Research and Development in Biotechnology
Professional, Scientific, and Technical Services
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United States of America
FOSTER CITY