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Mirum's (MIRM) Livmarli Aids Sales but Overdependence Concerns
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Mirum Pharmaceuticals, Inc.’s (MIRM - Free Report) lead product, Livmarli (maralixibat), an orally administered ileal bile acid transporter (“IBAT”) inhibitor, is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) worldwide. Sales of Livmarli have been rising steadily since its approval and launch in 2021.
In March 2024, the FDA approved a label expansion for Livmarli oral solution to include the treatment of cholestatic pruritus in patients aged five years and older with progressive familial intrahepatic cholestasis (PFIC).
In the first quarter of 2024, Livmarli generated sales worth $42.8 million, reflecting an increase of almost 47% on a year-over-year basis. The FDA nod for the PFIC indication should drive sales further in 2024 and beyond.
A regulatory filing seeking label expansion for Livmarli in the EU for the PFIC indication is currently under review.
Shares of Mirum have plunged 16.9% year to date compared with the industry’s decrease of 5.7%.
Image Source: Zacks Investment Research
In August 2023, Mirum acquired all assets of Travere Therapeutics’ bile acid products, which added two other products to its commercial portfolio — Cholbam (cholic acid) capsules and Chenodal (chenodiol) tablets. Cholbam is approved for treating bile acid synthesis disorders and Zellweger spectrum disorders.
Chenodal is not currently approved for cerebrotendinous xanthomatosis (“CTX”) but has received a medical necessity medicine status from the FDA for the same. A new drug application seeking traditional approval for Chenodal in CTX is expected to be filed later this year.
The addition of these products has diversified Mirum's commercial portfolio by adding a new revenue stream, which should lower the heavy dependence on Livmarli.
Mirum is developing volixibat, an oral IBAT inhibitor, in two separate phase IIb studies for the treatment of primary sclerosing cholangitis and primary biliary cholangitis. The interim analysis data from both studies are expected shortly.
The continued demand for Livmarli and the addition of Cholbam and Chenodal should help Mirum establish a leading pediatric hepatology franchise. However, the company remains heavily dependent on Livmarli for revenues, which is a concern. Any regulatory setback for the drug will hurt the company’s growth prospects.
Also, Cholbam and Chenodal have just been added to Mirum’s portfolio. These products are yet to generate incremental sales. It remains to be seen whether they are able to reduce the heavy dependence on Livmarli for revenues.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 31.3%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 87.3%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 60.4%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 54.43%.
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Mirum's (MIRM) Livmarli Aids Sales but Overdependence Concerns
Mirum Pharmaceuticals, Inc.’s (MIRM - Free Report) lead product, Livmarli (maralixibat), an orally administered ileal bile acid transporter (“IBAT”) inhibitor, is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) worldwide. Sales of Livmarli have been rising steadily since its approval and launch in 2021.
In March 2024, the FDA approved a label expansion for Livmarli oral solution to include the treatment of cholestatic pruritus in patients aged five years and older with progressive familial intrahepatic cholestasis (PFIC).
In the first quarter of 2024, Livmarli generated sales worth $42.8 million, reflecting an increase of almost 47% on a year-over-year basis. The FDA nod for the PFIC indication should drive sales further in 2024 and beyond.
A regulatory filing seeking label expansion for Livmarli in the EU for the PFIC indication is currently under review.
Shares of Mirum have plunged 16.9% year to date compared with the industry’s decrease of 5.7%.
Image Source: Zacks Investment Research
In August 2023, Mirum acquired all assets of Travere Therapeutics’ bile acid products, which added two other products to its commercial portfolio — Cholbam (cholic acid) capsules and Chenodal (chenodiol) tablets. Cholbam is approved for treating bile acid synthesis disorders and Zellweger spectrum disorders.
Chenodal is not currently approved for cerebrotendinous xanthomatosis (“CTX”) but has received a medical necessity medicine status from the FDA for the same. A new drug application seeking traditional approval for Chenodal in CTX is expected to be filed later this year.
The addition of these products has diversified Mirum's commercial portfolio by adding a new revenue stream, which should lower the heavy dependence on Livmarli.
Mirum is developing volixibat, an oral IBAT inhibitor, in two separate phase IIb studies for the treatment of primary sclerosing cholangitis and primary biliary cholangitis. The interim analysis data from both studies are expected shortly.
The continued demand for Livmarli and the addition of Cholbam and Chenodal should help Mirum establish a leading pediatric hepatology franchise. However, the company remains heavily dependent on Livmarli for revenues, which is a concern. Any regulatory setback for the drug will hurt the company’s growth prospects.
Also, Cholbam and Chenodal have just been added to Mirum’s portfolio. These products are yet to generate incremental sales. It remains to be seen whether they are able to reduce the heavy dependence on Livmarli for revenues.
Mirum Pharmaceuticals, Inc. Price and Consensus
Mirum Pharmaceuticals, Inc. price-consensus-chart | Mirum Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Mirum currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Krystal Biotech, Inc. (KRYS - Free Report) , Marinus Pharmaceuticals, Inc. and Minerva Neurosciences, Inc. (NERV - 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 60 days, estimates for Krystal Biotech’s 2024 earnings per share have improved from $1.61 to $2.06. Earnings per share estimates for 2025 have improved from $3.69 to $4.33. Year to date, shares of KRYS have surged 31.3%.
KRYS’s earnings beat estimates in two of the trailing four quarters and missed the same on the remaining two occasions, the average negative surprise being 21.46%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87, while loss per share estimates for 2025 have narrowed from $1.97 to 90 cents. Year to date, shares of MRNS have plunged 87.3%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimates for 2025 have narrowed from $4.54 to $3.60. Year to date, shares of NERV have declined 60.4%.
NERV’s earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 54.43%.