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Mirum's (MIRM) Livmarli Gets FDA Nod for Expanded Use, Stock Up
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Mirum Pharmaceuticals (MIRM - Free Report) announced that the FDA has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in infants aged 3 months and older with Alagille syndrome (ALGS). Earlier, the drug was approved for patients aged 1 year and older. However, with this label expansion, the age of pediatric patients eligible for treatment with Livmarli has now been reduced from 1 year to 3 months. The stock of the company jumped 6.4% on Tuesday in response to the news.
In the past year, the shares of the company have risen 9.9% against the industry’s decline of 13.3%.
Image Source: Zacks Investment Research
The label expansion approval was based on the results from Mirum’s RISE study that evaluated Livmarli’s safety and tolerability for use in pediatric patients under 1 year of age with ALGS. Livmarli is currently approved in the United States (3 months and older) and in Europe (2 months and older) for the treatment of cholestatic pruritus in patients with ALGS.
ALGS is a rare genetic disorder characterized by an abnormally narrow, malformed and reduced number of bile ducts, causing bile accumulation in the liver and ultimately progressive liver disease. This condition is observed in one out of every 30,000 people. The pruritus experienced by patients with ALGS is among the most severe in any chronic liver disease and is present in most affected children by 3 years of age.
Last month, the company submitted a supplemental new drug application (sNDA) to further expand the indication of Livmarli for treating cholestatic pruritus in patients 2 months of age and older with progressive familial intrahepatic cholestasis (PFIC). This submission was based on positive data from its phase III MARCH PFIC study of Livmarli. The study showed statistically significant improvement in pruritus, serum bile acids, bilirubin and growth as measured by weight z-score in the patient group treated with Livmarli. Additionally, the sNDA is also supported by data from the company’s phase II INDIGO study of PFIC2 patients demonstrating transplant-free survival in all serum bile acid responders after more than five years of treatment with Livmarli.
The company is also evaluating Livmarli in a phase IIB/phase III EMBARK study for the treatment of other rare cholestatic liver diseases, including biliary atresia.
In the past 90 days, the estimates for Aptinyx’s 2023 loss per share have narrowed from 77 cents to 56 cents. In the past year, the shares of Aptinyx have fallen by 95.4%.
APTX’s earnings witnessed an average earnings surprise of 9.53%, beating all four estimates in the trailing four reported quarters.
In the past 90 days, the consensus estimate for 89Bio’s 2023 loss per share has narrowed from $2.67 to $2.45. In the past year, the shares of 89Bio have increased by 266.2%.
ETNB’s earnings witnessed an average earnings surprise of 12.55%, beating three out of four estimates in the trailing four reported quarters, missing the mark on one occasion.
In the past 90 days, the consensus estimate for Annovis’ 2023 loss per share has widened from $2.94 to $3.87. In the past year, the shares of Annovis have increased by 22.7%.
ANVS’ reported loss per share was narrower than the estimated loss per share in the last reported quarter, delivering an earnings surprise of 20.51%.
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Mirum's (MIRM) Livmarli Gets FDA Nod for Expanded Use, Stock Up
Mirum Pharmaceuticals (MIRM - Free Report) announced that the FDA has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in infants aged 3 months and older with Alagille syndrome (ALGS). Earlier, the drug was approved for patients aged 1 year and older. However, with this label expansion, the age of pediatric patients eligible for treatment with Livmarli has now been reduced from 1 year to 3 months. The stock of the company jumped 6.4% on Tuesday in response to the news.
In the past year, the shares of the company have risen 9.9% against the industry’s decline of 13.3%.
Image Source: Zacks Investment Research
The label expansion approval was based on the results from Mirum’s RISE study that evaluated Livmarli’s safety and tolerability for use in pediatric patients under 1 year of age with ALGS. Livmarli is currently approved in the United States (3 months and older) and in Europe (2 months and older) for the treatment of cholestatic pruritus in patients with ALGS.
ALGS is a rare genetic disorder characterized by an abnormally narrow, malformed and reduced number of bile ducts, causing bile accumulation in the liver and ultimately progressive liver disease. This condition is observed in one out of every 30,000 people. The pruritus experienced by patients with ALGS is among the most severe in any chronic liver disease and is present in most affected children by 3 years of age.
Last month, the company submitted a supplemental new drug application (sNDA) to further expand the indication of Livmarli for treating cholestatic pruritus in patients 2 months of age and older with progressive familial intrahepatic cholestasis (PFIC). This submission was based on positive data from its phase III MARCH PFIC study of Livmarli. The study showed statistically significant improvement in pruritus, serum bile acids, bilirubin and growth as measured by weight z-score in the patient group treated with Livmarli. Additionally, the sNDA is also supported by data from the company’s phase II INDIGO study of PFIC2 patients demonstrating transplant-free survival in all serum bile acid responders after more than five years of treatment with Livmarli.
The company is also evaluating Livmarli in a phase IIB/phase III EMBARK study for the treatment of other rare cholestatic liver diseases, including biliary atresia.
Mirum Pharmaceuticals, Inc. Price and Consensus
Mirum Pharmaceuticals, Inc. price-consensus-chart | Mirum Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Mirum currently has a Zacks Rank #4 (Sell).
Some better-ranked stocks in the same industry are Aptinyx , 89Bio (ETNB - Free Report) and Annovis Bio (ANVS - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the estimates for Aptinyx’s 2023 loss per share have narrowed from 77 cents to 56 cents. In the past year, the shares of Aptinyx have fallen by 95.4%.
APTX’s earnings witnessed an average earnings surprise of 9.53%, beating all four estimates in the trailing four reported quarters.
In the past 90 days, the consensus estimate for 89Bio’s 2023 loss per share has narrowed from $2.67 to $2.45. In the past year, the shares of 89Bio have increased by 266.2%.
ETNB’s earnings witnessed an average earnings surprise of 12.55%, beating three out of four estimates in the trailing four reported quarters, missing the mark on one occasion.
In the past 90 days, the consensus estimate for Annovis’ 2023 loss per share has widened from $2.94 to $3.87. In the past year, the shares of Annovis have increased by 22.7%.
ANVS’ reported loss per share was narrower than the estimated loss per share in the last reported quarter, delivering an earnings surprise of 20.51%.