Mirum Pharmaceuticals Unveils New Liver Disease Treatment Data
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 33 minutes ago
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Source: Newsfilter
- VISTAS Study Results: In patients with primary sclerosing cholangitis (PSC), treatment with volixibat led to a significant average reduction of 2.72 points in pruritus scores, with 56% of patients achieving a ≥2 point reduction, indicating the drug's potential to enhance patient quality of life.
- AZURE-1 Study Findings: In chronic hepatitis delta virus (HDV) patients, brelovitug demonstrated a 100% virologic response rate at 24 weeks, with ALT normalization rates of 45% and 40%, showcasing its efficacy and safety in advanced disease patients, potentially offering new treatment options for HDV.
- Improved EFS with LIVMARLI: PFIC patients treated with LIVMARLI (maralixibat) showed a significant improvement in event-free survival (EFS) compared to a control cohort, with an HR of 0.29 (p=0.0001), suggesting the drug's potential in long-term PFIC management and improved patient outcomes.
- Future Plans: Mirum is set to submit an NDA for volixibat to the FDA in the second half of 2026 and anticipates the commercial launch of brelovitug in 2027, reflecting the company's ongoing development and market potential in rare liver diseases.
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Analyst Views on MIRM
Wall Street analysts forecast MIRM stock price to rise
9 Analyst Rating
9 Buy
0 Hold
0 Sell
Strong Buy
Current: 99.600
Low
81.00
Averages
102.33
High
140.00
Current: 99.600
Low
81.00
Averages
102.33
High
140.00
About MIRM
Mirum Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on the treatment of rare diseases affecting children and adults. It has three medicines: LIVMARLI (maralixibat) oral solution (Livmarli), Cholbam (cholic acid) capsules, and Chenodal or Ctexli (chenodiol) tablets. Livmarli is an orally administered, minimally-absorbed ileal bile acid transporter (IBAT) inhibitor (IBATi) that is used for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the United States and various other countries and for cholestatic pruritus in patient with progressive familial intrahepatic cholestasis (PFIC) in the United States, Canada and Japan. Cholbam is used for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders. The Company is also advancing its product candidate, volixibat, for the treatment of adult patients with cholestatic liver diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Mirum Pharmaceuticals Unveils New Liver Disease Treatment Data
- VISTAS Study Results: In patients with primary sclerosing cholangitis (PSC), treatment with volixibat led to a significant average reduction of 2.72 points in pruritus scores, with 56% of patients achieving a ≥2 point reduction, indicating the drug's potential to enhance patient quality of life.
- AZURE-1 Study Findings: In chronic hepatitis delta virus (HDV) patients, brelovitug demonstrated a 100% virologic response rate at 24 weeks, with ALT normalization rates of 45% and 40%, showcasing its efficacy and safety in advanced disease patients, potentially offering new treatment options for HDV.
- Improved EFS with LIVMARLI: PFIC patients treated with LIVMARLI (maralixibat) showed a significant improvement in event-free survival (EFS) compared to a control cohort, with an HR of 0.29 (p=0.0001), suggesting the drug's potential in long-term PFIC management and improved patient outcomes.
- Future Plans: Mirum is set to submit an NDA for volixibat to the FDA in the second half of 2026 and anticipates the commercial launch of brelovitug in 2027, reflecting the company's ongoing development and market potential in rare liver diseases.
See More
Mirum Pharmaceuticals Completes $600M Convertible Note Offering
- Convertible Note Offering: Mirum Pharmaceuticals successfully priced a $600 million private offering of convertible senior notes, expected to close on May 15, 2026, which will enhance the company's capital structure and financial flexibility.
- Use of Proceeds: The company plans to utilize approximately $475 million of the proceeds along with about 3.2 million shares to exchange approximately $237.2 million principal amount of its existing 4.00% convertible senior notes, thereby reducing future interest burdens and improving cash flow.
- Market Reaction: Following the announcement of the private offering, Mirum's stock traded about 2.3% lower in pre-market trading on Wednesday, reflecting market concerns regarding the company's financial health and cautious sentiment towards future performance.
- Revised Sales Outlook: Mirum raised its 2026 net product sales outlook to $660 million to $680 million, indicating strong confidence in the market potential of zilurgisertib, despite reporting a GAAP EPS of -$13.43 that missed expectations by $13.06.
See More
Mirum Pharmaceuticals Prices $600 Million Convertible Notes Offering
- Offering Size: Mirum Pharmaceuticals announced the pricing of $600 million in aggregate principal amount of 0.00% convertible senior notes, scheduled to settle on May 15, 2026, demonstrating the company's strong financing capability and market confidence in the rare disease sector.
- Conversion Terms: The initial conversion rate is set at 7.1971 shares of common stock per $1,000 principal amount, with a conversion price of approximately $138.94, representing a 30% premium over the last reported price of $106.88 on May 12, 2026, providing investors with potential capital appreciation opportunities.
- Use of Proceeds: Mirum expects to use approximately $475 million of the net proceeds to exchange for the 2029 convertible notes and plans to allocate the remaining funds for general corporate purposes, including the acquisition of complementary products and technologies, further driving its growth strategy.
- Market Impact: The bond offering may lead to increased buying activity in Mirum's common stock, particularly from hedged holders of the 2029 notes, which could elevate the stock price in the short term, reflecting market optimism about the company's future growth potential.
See More
Mirum Pharmaceuticals Q1 2026 Earnings Call Insights
- Revenue Guidance Raised: Mirum Pharmaceuticals has raised its full-year revenue guidance for 2026 to $660 million to $680 million, reflecting strong demand for LIVMARLI in the U.S. market, which is expected to drive performance growth in the coming months.
- Clinical Trial Progress: The VISTAS study demonstrated significant improvement in pruritus with volixibat, positioning it as a potential first approved medicine in the U.S., further solidifying Mirum's market position in liver disease treatment.
- New Drug Launch Plans: The company has submitted a priority review application for zilurgisertib to the FDA, with a PDUFA date set for September 26, and if approved, it is expected to launch by year-end, potentially generating over $200 million in sales.
- Financial Performance Overview: First-quarter net product sales were approximately $160 million, and despite the impact of non-recurring expenses related to the acquisition of Bluejay Therapeutics, the company anticipates achieving positive cash flow next year, indicating strong growth potential ahead.
See More
Mirum's Drug Trial Shows Significant Itch Relief in Liver Disease
- Clinical Trial Success: Mirum's drug volixibat achieved its primary endpoint in a mid-stage study, showing a 2.72-point improvement on a standardized scale for 111 patients with moderate-to-severe itch, significantly outperforming the placebo group's 1.08-point improvement, indicating its clinical relevance in alleviating itch associated with liver diseases.
- FDA Approval Process: Mirum plans to submit a New Drug Application in the second half of 2026 and has scheduled a pre-application meeting with the FDA, positioning volixibat as a potential therapy for PSC, a rare liver disease with no approved treatments, thus holding significant market potential.
- Positive Stock Market Reaction: Following the trial announcement, Mirum's shares closed 10% higher on Monday, marking its best performance since mid-December, reflecting investor optimism about the drug's prospects, with the stock gaining approximately 140% over the past 12 months.
- Retail Trader Sentiment Shift: On Stocktwits, retail sentiment around MIRM shifted from 'bearish' to 'extremely bullish', with message volume rising from 'normal' to 'extremely high', indicating market excitement over potential acquisition talks, with some users speculating a share price target of $160.
See More
Mirum Pharmaceuticals' VISTAS Study Achieves Success
- Clinical Trial Success: Mirum Pharmaceuticals' VISTAS Phase 2b study demonstrated that Volixibat met its primary endpoint in 158 patients with primary sclerosing cholangitis, indicating its potential as the first treatment for cholestatic pruritus.
- Significant Efficacy: Patients treated with 20 mg of Volixibat twice daily showed statistically significant improvements in pruritus within two weeks, particularly in the secondary cohort with mild itch at baseline, highlighting the drug's effectiveness.
- Positive Market Reaction: In pre-market trading, Mirum's stock rose by 3.58% to $99.99, reflecting investor optimism regarding the study results, which may enhance future market performance.
- Key Conference Presentation: The full results of the VISTAS Phase 2b study will be presented at the European Association for the Study of the Liver International Liver Congress on May 30, further elevating the company's profile in liver disease treatment.
See More
Mirum Pharmaceuticals Unveils New Liver Disease Treatment Data
- VISTAS Study Results: In patients with primary sclerosing cholangitis (PSC), treatment with volixibat led to a significant average reduction of 2.72 points in pruritus scores, with 56% of patients achieving a ≥2 point reduction, indicating the drug's potential to enhance patient quality of life.
- AZURE-1 Study Findings: In chronic hepatitis delta virus (HDV) patients, brelovitug demonstrated a 100% virologic response rate at 24 weeks, with ALT normalization rates of 45% and 40%, showcasing its efficacy and safety in advanced disease patients, potentially offering new treatment options for HDV.
- Improved EFS with LIVMARLI: PFIC patients treated with LIVMARLI (maralixibat) showed a significant improvement in event-free survival (EFS) compared to a control cohort, with an HR of 0.29 (p=0.0001), suggesting the drug's potential in long-term PFIC management and improved patient outcomes.
- Future Plans: Mirum is set to submit an NDA for volixibat to the FDA in the second half of 2026 and anticipates the commercial launch of brelovitug in 2027, reflecting the company's ongoing development and market potential in rare liver diseases.
See More
Mirum Pharmaceuticals Completes $600M Convertible Note Offering
- Convertible Note Offering: Mirum Pharmaceuticals successfully priced a $600 million private offering of convertible senior notes, expected to close on May 15, 2026, which will enhance the company's capital structure and financial flexibility.
- Use of Proceeds: The company plans to utilize approximately $475 million of the proceeds along with about 3.2 million shares to exchange approximately $237.2 million principal amount of its existing 4.00% convertible senior notes, thereby reducing future interest burdens and improving cash flow.
- Market Reaction: Following the announcement of the private offering, Mirum's stock traded about 2.3% lower in pre-market trading on Wednesday, reflecting market concerns regarding the company's financial health and cautious sentiment towards future performance.
- Revised Sales Outlook: Mirum raised its 2026 net product sales outlook to $660 million to $680 million, indicating strong confidence in the market potential of zilurgisertib, despite reporting a GAAP EPS of -$13.43 that missed expectations by $13.06.
See More
Mirum Pharmaceuticals Prices $600 Million Convertible Notes Offering
- Offering Size: Mirum Pharmaceuticals announced the pricing of $600 million in aggregate principal amount of 0.00% convertible senior notes, scheduled to settle on May 15, 2026, demonstrating the company's strong financing capability and market confidence in the rare disease sector.
- Conversion Terms: The initial conversion rate is set at 7.1971 shares of common stock per $1,000 principal amount, with a conversion price of approximately $138.94, representing a 30% premium over the last reported price of $106.88 on May 12, 2026, providing investors with potential capital appreciation opportunities.
- Use of Proceeds: Mirum expects to use approximately $475 million of the net proceeds to exchange for the 2029 convertible notes and plans to allocate the remaining funds for general corporate purposes, including the acquisition of complementary products and technologies, further driving its growth strategy.
- Market Impact: The bond offering may lead to increased buying activity in Mirum's common stock, particularly from hedged holders of the 2029 notes, which could elevate the stock price in the short term, reflecting market optimism about the company's future growth potential.
See More
Mirum Pharmaceuticals Q1 2026 Earnings Call Insights
- Revenue Guidance Raised: Mirum Pharmaceuticals has raised its full-year revenue guidance for 2026 to $660 million to $680 million, reflecting strong demand for LIVMARLI in the U.S. market, which is expected to drive performance growth in the coming months.
- Clinical Trial Progress: The VISTAS study demonstrated significant improvement in pruritus with volixibat, positioning it as a potential first approved medicine in the U.S., further solidifying Mirum's market position in liver disease treatment.
- New Drug Launch Plans: The company has submitted a priority review application for zilurgisertib to the FDA, with a PDUFA date set for September 26, and if approved, it is expected to launch by year-end, potentially generating over $200 million in sales.
- Financial Performance Overview: First-quarter net product sales were approximately $160 million, and despite the impact of non-recurring expenses related to the acquisition of Bluejay Therapeutics, the company anticipates achieving positive cash flow next year, indicating strong growth potential ahead.
See More
Mirum's Drug Trial Shows Significant Itch Relief in Liver Disease
- Clinical Trial Success: Mirum's drug volixibat achieved its primary endpoint in a mid-stage study, showing a 2.72-point improvement on a standardized scale for 111 patients with moderate-to-severe itch, significantly outperforming the placebo group's 1.08-point improvement, indicating its clinical relevance in alleviating itch associated with liver diseases.
- FDA Approval Process: Mirum plans to submit a New Drug Application in the second half of 2026 and has scheduled a pre-application meeting with the FDA, positioning volixibat as a potential therapy for PSC, a rare liver disease with no approved treatments, thus holding significant market potential.
- Positive Stock Market Reaction: Following the trial announcement, Mirum's shares closed 10% higher on Monday, marking its best performance since mid-December, reflecting investor optimism about the drug's prospects, with the stock gaining approximately 140% over the past 12 months.
- Retail Trader Sentiment Shift: On Stocktwits, retail sentiment around MIRM shifted from 'bearish' to 'extremely bullish', with message volume rising from 'normal' to 'extremely high', indicating market excitement over potential acquisition talks, with some users speculating a share price target of $160.
See More
Mirum Pharmaceuticals' VISTAS Study Achieves Success
- Clinical Trial Success: Mirum Pharmaceuticals' VISTAS Phase 2b study demonstrated that Volixibat met its primary endpoint in 158 patients with primary sclerosing cholangitis, indicating its potential as the first treatment for cholestatic pruritus.
- Significant Efficacy: Patients treated with 20 mg of Volixibat twice daily showed statistically significant improvements in pruritus within two weeks, particularly in the secondary cohort with mild itch at baseline, highlighting the drug's effectiveness.
- Positive Market Reaction: In pre-market trading, Mirum's stock rose by 3.58% to $99.99, reflecting investor optimism regarding the study results, which may enhance future market performance.
- Key Conference Presentation: The full results of the VISTAS Phase 2b study will be presented at the European Association for the Study of the Liver International Liver Congress on May 30, further elevating the company's profile in liver disease treatment.
See More
