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 (MIRM) delivers innovative therapies for rare liver diseases through targeted IBAT inhibitor development. This page provides centralized access to official announcements, clinical trial updates, and strategic developments from the biopharmaceutical innovator.
Investors and healthcare professionals will find timely updates on regulatory milestones, partnership agreements, and pipeline advancements. Our curated feed includes verified press releases about Maralixibat approvals, Volixibat trial progress, and corporate initiatives addressing conditions like progressive familial intrahepatic cholestasis.
Key updates cover FDA communications, research collaborations, and commercialization strategies for orphan drug therapies. All content is sourced directly from Mirum’s disclosures to ensure accuracy and compliance with financial reporting standards.
Bookmark this page for streamlined access to Mirum’s latest advancements in minimally absorbed liver disease treatments. Check regularly for critical updates impacting clinical development timelines and therapeutic availability.
Mirum Pharmaceuticals presented promising 28-week data from its Phase 2b VANTAGE study evaluating volixibat for cholestatic pruritus in primary biliary cholangitis (PBC) patients at EASL. The study showed statistically significant improvements in pruritus (itching) and numeric improvements in fatigue, the two most burdensome PBC symptoms.
Key findings include:
- 70% of volixibat-treated patients achieved ≥50% reduction in serum bile acids
- Statistically significant 3.78-point reduction in ItchRO from baseline in the combined dose group
- Both 20mg and 80mg BID doses showed similar efficacy
- Improvements in quality of life measures and reductions in IL-31 inflammatory biomarker
The most common adverse event was mild to moderate diarrhea (77%). Based on similar efficacy and safety results, the 20mg BID dose was selected for the confirmatory portion of the VANTAGE study.
Mirum Pharmaceuticals (NASDAQ: MIRM) has scheduled its first quarter 2025 financial results announcement for Wednesday, May 7, 2025. The company will host a conference call at 4:30 p.m. ET / 1:30 p.m. PT to discuss both the financial performance and recent corporate developments.
Investors and interested parties can access the call through multiple channels:
- U.S./Toll-Free: +1 833 470 1428
- International: +1 404 975 4839
- Passcode: 549600
Additionally, a webcast will be available through the Events & Presentations section on Mirum's website. For those unable to attend live, a replay of the webcast will remain accessible for 30 days following the call.
Mirum Pharmaceuticals (NASDAQ: MIRM) has announced upcoming data presentations at three major medical congresses in May 2025: Digestive Disease Week (DDW) in San Diego, European Association for the Study of the Liver (EASL) in Amsterdam, and ESPGHAN in Helsinki.
A key highlight includes new 28-week data from the Phase 2b VANTAGE study of volixibat in PBC patients, showing significant improvements in cholestatic pruritus. The study demonstrated that 70% of volixibat-treated patients achieved ≥50% reduction in serum bile acid levels, with improvements in fatigue and sleep. The most common side effect was mild to moderate diarrhea.
The presentations will feature data from LIVMARLI and volixibat studies across multiple sessions, including oral presentations, posters, and symposiums focusing on cholestatic liver diseases, PFIC, and Alagille syndrome treatment outcomes.
Mirum Pharmaceuticals (NASDAQ: MIRM) has received FDA approval for a new tablet formulation of LIVMARLI® (maralixibat) for treating cholestatic pruritus in patients with Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
The tablet version will complement the existing liquid formulation, offering greater flexibility in treatment options. While younger patients can continue using the liquid form, older patients will benefit from a convenient one-tablet per dose option. The company plans to make LIVMARLI tablets available in June through Mirum Access Plus.
Mirum Pharmaceuticals (MIRM) has announced inducement awards for seven new employees under its 2020 Inducement Plan. The awards, approved by the Compensation Committee, include:
- 39,740 non-qualified stock options with an exercise price of $39.12 per share (closing price on April 10, 2025)
- 19,830 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. Both awards are contingent on continued employment with Mirum through vesting dates.
Mirum Pharmaceuticals (NASDAQ: MIRM) announced that its partner Takeda Pharmaceutical has received approval from the Japanese Ministry of Health, Labour, and Welfare for LIVMARLI® (maralixibat) oral solution. The approval is for treating cholestatic pruritus in patients with Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC) in Japan.
LIVMARLI becomes the first and only treatment available for these conditions in Japan. Under the exclusive license agreement signed in September 2021, Mirum will receive a percentage of Takeda's annual net sales. The medication is currently approved for ALGS-related pruritus in over 40 countries and for PFIC in more than 30 countries worldwide.
Mirum Pharmaceuticals (Nasdaq: MIRM) announced inducement awards granted by its Compensation Committee on March 10, 2025, to five new employees. The awards include:
- Non-qualified stock options to purchase 17,620 shares at $43.01 per share (closing price on March 10, 2025)
- 9,290 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. Both awards require continued employment with Mirum and were granted under the company's 2020 Inducement Plan in accordance with Nasdaq Listing Rule 5635(c)(4).
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.
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