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Mirum's Livmarli Meets Phase III Goal in Ultra-Rare Liver Diseases
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Key Takeaways
Mirum's Livmarli met the primary endpoint in the Phase III EXPAND study of ultra-rare liver diseases.
Livmarli improved itch severity by 1.81 points versus 0.83 for placebo and reduced serum bile acids by 69%.
Mirum plans to submit an sNDA to the FDA in the first half of 2027 following positive EXPAND results.
Mirum Pharmaceuticals (MIRM - Free Report) announced that the phase III EXPAND study, which evaluated Livmarli (maralixibat) for treating cholestatic pruritus in patients aged six months and older with ultra-rare cholestatic liver diseases, including biliary atresia, has met its primary endpoint.
What Did MIRM’s EXPAND Study Data Show?
Data from the study showed that treatment with Livmarli led to a statistically significant improvement in cholestatic pruritus compared with placebo in the primary analysis population of pediatric patients.
Treatment with Livmarli showed a mean 1.81-point improvement from baseline in the average worst-daily ItchRO(Obs) severity score during weeks 13-20, compared with a 0.83-point improvement for placebo. Treatment with Livmarli also achieved a 69% reduction in serum bile acids versus placebo.
The EXPAND study also met all five prespecified secondary endpoints, including the three endpoints evaluated in patients with biliary atresia and a native liver. In these patients, Livmarli demonstrated a statistically significant improvement in cholestatic pruritus compared with placebo.
Based on the positive data from the EXPAND study, Mirum plans to submit a supplemental new drug application (sNDA) for Livmarli to the FDA in the first half of 2027.
In March 2026, Mirum completed enrollment in the phase III EXPAND study.
Year to date, shares of Mirum have increased 9% compared with the industry’s rise of 3.7%.
Image Source: Zacks Investment Research
MIRM Thrives on Livmarli Sales Uptake
Mirum’s lead marketed drug, Livmarli, is presently approved for treating cholestatic pruritus in patients with Alagille syndrome worldwide. The drug is also approved for treating certain patients with progressive familial intrahepatic cholestasis in the United States and Europe.
The FDA has also approved a new tablet formulation of Livmarli for the treatment of cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis. The oral tablet, which was launched in the United States in June 2025, is likely to offer convenience for older patients.
Sales of Livmarli have been rising steadily since its approval and launch worldwide. In the first half of 2026, Livmarli generated sales worth $242.5 million, indicating an increase of 50.2% on a year-over-year basis. The continued demand for Livmarli is driving the top line and the momentum is expected to continue for the rest of 2026. Reflecting the strong performance of its business so far in 2026, Mirum now expects total revenues to be in the range of $680-$700 million in 2026, compared with the previous expectation of $660-$680 million.
Potential label expansion of Livmarli is likely to drive sales further in the future quarters.
Over the past 60 days, estimates for Werewolf Therapeutics’ 2026 loss per share have narrowed from $1.49 to 89 cents, while loss per share estimates for 2027 have narrowed from $2.20 to 59 cents during the same time. HOWL’s shares have gained 55% year to date.
Werewolf Therapeutics’ earnings beat estimates in each of the trailing four quarters, with the average being 47.49%.
Over the past 60 days, estimates for Arvinas’ 2026 bottom line have improved from a loss of 27 cents per share to earnings of 5 cents, while loss per share estimates for 2027 have narrowed from $3.44 to $3.37 during the same time. ARVN shares have declined 37.1% year to date.
Arvinas’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 279.07%.
Over the past 60 days, estimates for Eton Pharmaceuticals’ 2026 earnings per share have risen from 75 cents to $1.13, while estimates for 2027 have increased from $1.91 to $1.94 during the same time. ETON shares have skyrocketed 226.8% year to date.
Eton Pharmaceuticals’ earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, with the average negative surprise being 11.00%.
View the Zacks #1 Rank List
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Mirum's Livmarli Meets Phase III Goal in Ultra-Rare Liver Diseases
Key Takeaways
Mirum Pharmaceuticals (MIRM - Free Report) announced that the phase III EXPAND study, which evaluated Livmarli (maralixibat) for treating cholestatic pruritus in patients aged six months and older with ultra-rare cholestatic liver diseases, including biliary atresia, has met its primary endpoint.
What Did MIRM’s EXPAND Study Data Show?
Data from the study showed that treatment with Livmarli led to a statistically significant improvement in cholestatic pruritus compared with placebo in the primary analysis population of pediatric patients.
Treatment with Livmarli showed a mean 1.81-point improvement from baseline in the average worst-daily ItchRO(Obs) severity score during weeks 13-20, compared with a 0.83-point improvement for placebo. Treatment with Livmarli also achieved a 69% reduction in serum bile acids versus placebo.
The EXPAND study also met all five prespecified secondary endpoints, including the three endpoints evaluated in patients with biliary atresia and a native liver. In these patients, Livmarli demonstrated a statistically significant improvement in cholestatic pruritus compared with placebo.
Based on the positive data from the EXPAND study, Mirum plans to submit a supplemental new drug application (sNDA) for Livmarli to the FDA in the first half of 2027.
In March 2026, Mirum completed enrollment in the phase III EXPAND study.
Year to date, shares of Mirum have increased 9% compared with the industry’s rise of 3.7%.
Image Source: Zacks Investment Research
MIRM Thrives on Livmarli Sales Uptake
Mirum’s lead marketed drug, Livmarli, is presently approved for treating cholestatic pruritus in patients with Alagille syndrome worldwide. The drug is also approved for treating certain patients with progressive familial intrahepatic cholestasis in the United States and Europe.
The FDA has also approved a new tablet formulation of Livmarli for the treatment of cholestatic pruritus in patients with Alagille syndrome and progressive familial intrahepatic cholestasis. The oral tablet, which was launched in the United States in June 2025, is likely to offer convenience for older patients.
Sales of Livmarli have been rising steadily since its approval and launch worldwide. In the first half of 2026, Livmarli generated sales worth $242.5 million, indicating an increase of 50.2% on a year-over-year basis. The continued demand for Livmarli is driving the top line and the momentum is expected to continue for the rest of 2026. Reflecting the strong performance of its business so far in 2026, Mirum now expects total revenues to be in the range of $680-$700 million in 2026, compared with the previous expectation of $660-$680 million.
Potential label expansion of Livmarli is likely to drive sales further in the future quarters.
MIRM's Zacks Rank & Other Stocks to Consider
Mirum currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Werewolf Therapeutics (HOWL - Free Report) , Arvinas (ARVN - Free Report) and Eton Pharmaceuticals (ETON - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Werewolf Therapeutics’ 2026 loss per share have narrowed from $1.49 to 89 cents, while loss per share estimates for 2027 have narrowed from $2.20 to 59 cents during the same time. HOWL’s shares have gained 55% year to date.
Werewolf Therapeutics’ earnings beat estimates in each of the trailing four quarters, with the average being 47.49%.
Over the past 60 days, estimates for Arvinas’ 2026 bottom line have improved from a loss of 27 cents per share to earnings of 5 cents, while loss per share estimates for 2027 have narrowed from $3.44 to $3.37 during the same time. ARVN shares have declined 37.1% year to date.
Arvinas’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 279.07%.
Over the past 60 days, estimates for Eton Pharmaceuticals’ 2026 earnings per share have risen from 75 cents to $1.13, while estimates for 2027 have increased from $1.91 to $1.94 during the same time. ETON shares have skyrocketed 226.8% year to date.
Eton Pharmaceuticals’ earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, with the average negative surprise being 11.00%.