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Vertex (VRTX) Gets Nod in EU for Orkambi Expanded Indication
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Vertex Pharmaceuticals (VRTX - Free Report) announced that the European Commission has approved the label expansion of Orkambi (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) aged 1 to <2 years old who have two copies of the F508del mutation, the most common form of the disease.
Vertex’s Orkambi, a combination of lumacaftor and ivacaftor, is an orally administered medicine. The drug was first approved in the EU in 2015 in patients aged 12 years and older for the same indication. With this label extension, Orkambi is now approved in the EU for patients aged 1 year and older with CF who have two copies of the F508del mutation. Orkambi is available for treatment in more than 30 countries worldwide.
Besides the EU, Orkambi has also been approved by regulatory authorities in the United States, Great Britain, Australia and Canada, for people with CF and two copies of the F508del mutation in the CFTR gene, aged 1 and above.
Year to date, shares of Vertex have surged 20.6% against the industry’s 10.2% fall.
Image Source: Zacks Investment Research
In the last reported quarter, Orkambi generated sales of $122.5 million, accounting for only 5% of Vertex’s total revenues. The label extension of the drug will expand its targeted patient population. This will likely result in increased sales of the drug in the upcoming quarters.
A long-term reimbursement agreement in the U.K. has granted children aged 1 to <2 years old to have access to this expanded indication for Orkambi since approval by the respective regulatory body in March 2023. Furthermore, Vertex intends to continue to work with reimbursement bodies across the EU, Australia and Canada to ensure access for all eligible patients.
While CF remains the main area of focus, VRTX is also developing treatments for sickle cell disease (SCD), transfusion-dependent beta-thalassemia (TDT), acute and neuropathic pain, APOL1-mediated kidney disease, type I diabetes, alpha-1 antitrypsin deficiency, and also has earlier-stage programs in diseases, such as muscular dystrophies.
Most notable among these non-CF indications is Vertex’s collaboration agreement with CRISPR Therapeutics (CRSP - Free Report) for the development and commercialization of exagamglogene autotemcel (exa-cel) to treat SCD and TDT.
In the United States, the FDA granted priority review to the biologics license applications (BLAs) filing for exa-cel in SCD indication, while the exa-cel filing in TDT indication has been accepted for a standard review by the agency. Final decisions on the BLAs for exa-cel in SCD and TDT indications are expected by Dec 8, 2023, and Mar 30, 2024, respectively.
The FDA nod to exa-cel will also make it Vertex’s first marketed product approved in a non-CF indication. Vertex expects exa-cel to be its next commercial launch.
Vertex Pharmaceuticals Incorporated Price and Consensus
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 14 cents to 9 cents. The consensus estimate for 2024 earnings is currently pegged at 7 cents per share. Year to date, shares of ADMA have lost 6.7%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.92 to $2.80. During the same period, the estimate for AKRO’s 2024 loss per share has narrowed from $3.31 to $3.27. Year to date, shares of AKRO have lost 17.8%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
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Vertex (VRTX) Gets Nod in EU for Orkambi Expanded Indication
Vertex Pharmaceuticals (VRTX - Free Report) announced that the European Commission has approved the label expansion of Orkambi (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) aged 1 to <2 years old who have two copies of the F508del mutation, the most common form of the disease.
Vertex’s Orkambi, a combination of lumacaftor and ivacaftor, is an orally administered medicine. The drug was first approved in the EU in 2015 in patients aged 12 years and older for the same indication. With this label extension, Orkambi is now approved in the EU for patients aged 1 year and older with CF who have two copies of the F508del mutation. Orkambi is available for treatment in more than 30 countries worldwide.
Besides the EU, Orkambi has also been approved by regulatory authorities in the United States, Great Britain, Australia and Canada, for people with CF and two copies of the F508del mutation in the CFTR gene, aged 1 and above.
Year to date, shares of Vertex have surged 20.6% against the industry’s 10.2% fall.
Image Source: Zacks Investment Research
In the last reported quarter, Orkambi generated sales of $122.5 million, accounting for only 5% of Vertex’s total revenues. The label extension of the drug will expand its targeted patient population. This will likely result in increased sales of the drug in the upcoming quarters.
A long-term reimbursement agreement in the U.K. has granted children aged 1 to <2 years old to have access to this expanded indication for Orkambi since approval by the respective regulatory body in March 2023. Furthermore, Vertex intends to continue to work with reimbursement bodies across the EU, Australia and Canada to ensure access for all eligible patients.
While CF remains the main area of focus, VRTX is also developing treatments for sickle cell disease (SCD), transfusion-dependent beta-thalassemia (TDT), acute and neuropathic pain, APOL1-mediated kidney disease, type I diabetes, alpha-1 antitrypsin deficiency, and also has earlier-stage programs in diseases, such as muscular dystrophies.
Most notable among these non-CF indications is Vertex’s collaboration agreement with CRISPR Therapeutics (CRSP - Free Report) for the development and commercialization of exagamglogene autotemcel (exa-cel) to treat SCD and TDT.
In the United States, the FDA granted priority review to the biologics license applications (BLAs) filing for exa-cel in SCD indication, while the exa-cel filing in TDT indication has been accepted for a standard review by the agency. Final decisions on the BLAs for exa-cel in SCD and TDT indications are expected by Dec 8, 2023, and Mar 30, 2024, respectively.
The FDA nod to exa-cel will also make it Vertex’s first marketed product approved in a non-CF indication. Vertex expects exa-cel to be its next commercial launch.
Vertex Pharmaceuticals Incorporated Price and Consensus
Vertex Pharmaceuticals Incorporated price-consensus-chart | Vertex Pharmaceuticals Incorporated Quote
Zacks Rank and Other Stocks to Consider
Vertex currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are ADMA Biologics, Inc. (ADMA - Free Report) and Akero Therapeutics (AKRO - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 14 cents to 9 cents. The consensus estimate for 2024 earnings is currently pegged at 7 cents per share. Year to date, shares of ADMA have lost 6.7%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.92 to $2.80. During the same period, the estimate for AKRO’s 2024 loss per share has narrowed from $3.31 to $3.27. Year to date, shares of AKRO have lost 17.8%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.