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Mirum Pharma (MIRM) Stock Rises 42% Year to Date: Here's Why
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Mirum Pharmaceuticals (MIRM - Free Report) , a commercial-stage company, operates in the rare liver diseases market and generates revenues from the sale of its only marketed product, Livmarli (maralixibat). Livmarli, an orally administered, once-daily and ileal bile acid transporter (IBAT) inhibitor, was initially approved in the United States to treat cholestatic pruritus patients aged one year or older with Alagille syndrome.
In the EU, the drug is approved for the same indication for patients aged two months and older.
During this year, the company announced several regulatory updates regarding the label expansion of Livmarli, along with strategic initiatives, to expand its portfolio in the treatment of rare liver diseases.
Shares of Mirum Pharma have rallied 41.7% in the year-to-date period against the industry’s 13.2% fall.
Image Source: Zacks Investment Research
Earlier this year, the company announced that the FDA had approved the expansion of Livmarli’s label to reduce the age limit of the eligible patient population from 12 months to three months and older. This provided a significant boost to the company as more patients are now eligible to be treated with the drug.
Mirum Pharma is also looking to expand Livmarli’s indication. The company has already completed regulatory filings in the United States and EU to further expand the indication of Livmarli for treating cholestatic pruritus in patients aged two months and older with progressive familial intrahepatic cholestasis (PFIC).
Both regulatory applications seeking label extension were 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 supplemental new drug application is also supported by the data from the company’s phase II INDIGO study of PFIC2 (a sub-type of PFIC) patients demonstrating transplant-free survival in all serum bile acid responders after more than five years of treatment with Livmarli.
Furthermore, MIRM is also evaluating Livmarli in a phase IIB EMBARK study for the treatment of another rare cholestatic liver disease, biliary atresia. Top-line results from the same are expected in the second half of 2023.
Approval of Livmarli in these added indications will further expand patient eligibility, thereby, boosting revenues.
Apart from Livmarli, the company has another candidate in its pipeline, volixibat, an oral IBAT inhibitor, for the treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Two separate phase IIb studies, VISTAS and VANTAGE, are currently being conducted on volixibat in the PSC and PBC indications, respectively. Interim analysis results from both studies are expected in the second half of 2023.
Recently, the company also completed the acquisition of two of Travere Therapeutics’ (TVTX - Free Report) bile acid products, Cholbam (cholic acid) and Chenodal (chenodiol), which address rare diseases in high-need settings, for up to $445 million in total consideration. This transaction has granted MIRM exclusive rights to market Cholbam and Chenodal.
Cholbam is indicated for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients with signs or symptoms of liver disease. On the other hand, Chenodal is indicated for the treatment of radiolucent stones in the gallbladder. Currently, Chenodal is also being evaluated in a late-stage study to treat cerebrotendinous xanthomatosis.
Per Mirum Pharma, the two acquired commercial-stage products are highly complementary to Livmarli and have expanded its liver disease portfolio.
The commercialization of these two acquired products will also provide the company with an incremental stream of revenues.
Mirum Pharma currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the same industry are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 34 cents to 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 33.8%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has gone up from 75 cents to 78 cents. The estimate for Corcept’s 2024 earnings per share has also improved from 81 cents to 83 cents. Year to date, shares of CORT have climbed 55.8%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Mirum Pharma (MIRM) Stock Rises 42% Year to Date: Here's Why
Mirum Pharmaceuticals (MIRM - Free Report) , a commercial-stage company, operates in the rare liver diseases market and generates revenues from the sale of its only marketed product, Livmarli (maralixibat). Livmarli, an orally administered, once-daily and ileal bile acid transporter (IBAT) inhibitor, was initially approved in the United States to treat cholestatic pruritus patients aged one year or older with Alagille syndrome.
In the EU, the drug is approved for the same indication for patients aged two months and older.
During this year, the company announced several regulatory updates regarding the label expansion of Livmarli, along with strategic initiatives, to expand its portfolio in the treatment of rare liver diseases.
Shares of Mirum Pharma have rallied 41.7% in the year-to-date period against the industry’s 13.2% fall.
Image Source: Zacks Investment Research
Earlier this year, the company announced that the FDA had approved the expansion of Livmarli’s label to reduce the age limit of the eligible patient population from 12 months to three months and older. This provided a significant boost to the company as more patients are now eligible to be treated with the drug.
Mirum Pharma is also looking to expand Livmarli’s indication. The company has already completed regulatory filings in the United States and EU to further expand the indication of Livmarli for treating cholestatic pruritus in patients aged two months and older with progressive familial intrahepatic cholestasis (PFIC).
Both regulatory applications seeking label extension were 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 supplemental new drug application is also supported by the data from the company’s phase II INDIGO study of PFIC2 (a sub-type of PFIC) patients demonstrating transplant-free survival in all serum bile acid responders after more than five years of treatment with Livmarli.
Furthermore, MIRM is also evaluating Livmarli in a phase IIB EMBARK study for the treatment of another rare cholestatic liver disease, biliary atresia. Top-line results from the same are expected in the second half of 2023.
Approval of Livmarli in these added indications will further expand patient eligibility, thereby, boosting revenues.
Apart from Livmarli, the company has another candidate in its pipeline, volixibat, an oral IBAT inhibitor, for the treatment of primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC). Two separate phase IIb studies, VISTAS and VANTAGE, are currently being conducted on volixibat in the PSC and PBC indications, respectively. Interim analysis results from both studies are expected in the second half of 2023.
Recently, the company also completed the acquisition of two of Travere Therapeutics’ (TVTX - Free Report) bile acid products, Cholbam (cholic acid) and Chenodal (chenodiol), which address rare diseases in high-need settings, for up to $445 million in total consideration. This transaction has granted MIRM exclusive rights to market Cholbam and Chenodal.
Cholbam is indicated for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients with signs or symptoms of liver disease. On the other hand, Chenodal is indicated for the treatment of radiolucent stones in the gallbladder. Currently, Chenodal is also being evaluated in a late-stage study to treat cerebrotendinous xanthomatosis.
Per Mirum Pharma, the two acquired commercial-stage products are highly complementary to Livmarli and have expanded its liver disease portfolio.
The commercialization of these two acquired products will also provide the company with an incremental stream of revenues.
Mirum Pharmaceuticals, Inc. Price and Consensus
Mirum Pharmaceuticals, Inc. price-consensus-chart | Mirum Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Mirum Pharma currently has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the same industry are Dynavax Technologies (DVAX - Free Report) and Corcept Therapeutics (CORT - Free Report) , each 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 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has narrowed from 34 cents to 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 33.8%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has gone up from 75 cents to 78 cents. The estimate for Corcept’s 2024 earnings per share has also improved from 81 cents to 83 cents. Year to date, shares of CORT have climbed 55.8%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.