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Mirum's (MIRM) Livmarli Receives FDA Nod for Expanded Use
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Mirum Pharmaceuticals, Inc. (MIRM - Free Report) announced that the FDA had approved a label expansion for Livmarli (maralixibat) oral solution to include the treatment of cholestatic pruritus in patients aged five years and older with progressive familial intrahepatic cholestasis (PFIC). Livmarli is an orally administered ileal bile acid transporter inhibitor.
It is important to note that Livmarli is already approved in the United States and EU as the only medication for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged three months and older and two months and older, respectively. Mirum’s Livmarli is also currently approved in other geographies worldwide to treat the ALGS indication.
A regulatory filing seeking label expansion for Livmarli in the EU for patients aged two months and older with PFIC is currently under review.
In the past year, shares of MIRM have gained 21% against the industry’s 6.1% decline.
Image Source: Zacks Investment Research
The FDA approval of the application seeking label expansion of Livmarli in PFIC patients was based on positive data from Mirum’s phase III MARCH study. Results from the late-stage study demonstrated a statistically significant reduction in pruritus severity in patients treated with Livmarli compared with placebo.
The MARCH study enrolled 93 patients across a range of genetic PFIC typesand unidentified mutational status. Thus, the label update covers a broad range of PFIC subtypes.
The company also reported that it had submitted an additional supplemental new drug application seeking label expansion for a higher concentration formulation of Livmarli, which was used in the MARCH study to include treatment of younger patients with PFIC later in 2024.
PFIC is a rare genetic disorder that causes liver failure. PFIC patients lack the ability to secrete bile sufficiently, leading to the accumulation of bile and causing liver disease in affected individuals.
Per Mirum, PFIC approximately affects one in every 50,000 to 100,000 births in the United States and EU.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past year, shares of ADMA have surged 92.3%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past year, shares of FGEN have plunged 89.7%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has remained constant at $1.81. In the past year, shares of ACET have lost 73.4%.
ACET beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.
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Mirum's (MIRM) Livmarli Receives FDA Nod for Expanded Use
Mirum Pharmaceuticals, Inc. (MIRM - Free Report) announced that the FDA had approved a label expansion for Livmarli (maralixibat) oral solution to include the treatment of cholestatic pruritus in patients aged five years and older with progressive familial intrahepatic cholestasis (PFIC). Livmarli is an orally administered ileal bile acid transporter inhibitor.
It is important to note that Livmarli is already approved in the United States and EU as the only medication for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged three months and older and two months and older, respectively. Mirum’s Livmarli is also currently approved in other geographies worldwide to treat the ALGS indication.
A regulatory filing seeking label expansion for Livmarli in the EU for patients aged two months and older with PFIC is currently under review.
In the past year, shares of MIRM have gained 21% against the industry’s 6.1% decline.
Image Source: Zacks Investment Research
The FDA approval of the application seeking label expansion of Livmarli in PFIC patients was based on positive data from Mirum’s phase III MARCH study. Results from the late-stage study demonstrated a statistically significant reduction in pruritus severity in patients treated with Livmarli compared with placebo.
The MARCH study enrolled 93 patients across a range of genetic PFIC typesand unidentified mutational status. Thus, the label update covers a broad range of PFIC subtypes.
The company also reported that it had submitted an additional supplemental new drug application seeking label expansion for a higher concentration formulation of Livmarli, which was used in the MARCH study to include treatment of younger patients with PFIC later in 2024.
PFIC is a rare genetic disorder that causes liver failure. PFIC patients lack the ability to secrete bile sufficiently, leading to the accumulation of bile and causing liver disease in affected individuals.
Per Mirum, PFIC approximately affects one in every 50,000 to 100,000 births in the United States and EU.
Mirum Pharmaceuticals, Inc. Price and Consensus
Mirum Pharmaceuticals, Inc. price-consensus-chart | Mirum Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Mirum currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) , FibroGen (FGEN - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ACET carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has increased from 22 cents to 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has increased from 32 cents to 50 cents. In the past year, shares of ADMA have surged 92.3%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has narrowed from $1.14 to $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share is pegged at 6 cents. In the past year, shares of FGEN have plunged 89.7%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has remained constant at $1.81. In the past year, shares of ACET have lost 73.4%.
ACET beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.