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Vertex (VRTX) Gets Positive CHMP Opinion for Kaftrio Expanded Use
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Vertex Pharmaceuticals (VRTX - Free Report) announced that its triple combination cystic fibrosis (CF) therapy, Kaftrio,has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for expanded use to treat younger age groups of two to five years old.
The CHMP recommended extending the drug’s marketing authorization in the European Union (EU) in patients aged between six and eleven years who have at least one F508del mutation in the CF transmembrane conductance regulator gene in combination with Kalydeco (ivacaftor).
Vertex’s Kaftriois an orally administered medicine. The drug is already approved in the EU in patients aged six years and older for the same indication. Kaftrio is also approved in the United States under the brand name Trikafta to treat CF in people aged two years and older who have at least one F508del mutation.
Besides EU and the United States, Trikaftais approved by regulatory authorities in Great Britain, Australia and Canada, for people with CF aged six and above.
Shares of Vertex have risen 20.9% year to date against the industry’s 14.0% decline.
Image Source: Zacks Investment Research
VRTX enjoys a dominant position in the CF market. Trikafta/ Kaftrio generated revenues of $4.34 billion in the first half of 2023, accounting for almost 89% of the company’s total revenues. The label extension of the drug will expand its targeted patient population as more than 12,000 children will be eligible for the drug. This will likely result in increased sales of the drug in the upcoming quarters.
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. The company 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. Vertex believes exa-cel has the potential to be a one-time functional cure for SCD and TDT patients with an estimated patient population of approximately 32,000.
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 forAnika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.24 for 2023. The bottom-line estimate has widened from a loss of 79 cents to a loss of 82 cents for 2024 during the same time frame. Shares of the company have lost 41.0% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to a loss of $2.77 for 2024 during the same time frame. Shares of the company have lost 21.0% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
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Vertex (VRTX) Gets Positive CHMP Opinion for Kaftrio Expanded Use
Vertex Pharmaceuticals (VRTX - Free Report) announced that its triple combination cystic fibrosis (CF) therapy, Kaftrio,has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for expanded use to treat younger age groups of two to five years old.
The CHMP recommended extending the drug’s marketing authorization in the European Union (EU) in patients aged between six and eleven years who have at least one F508del mutation in the CF transmembrane conductance regulator gene in combination with Kalydeco (ivacaftor).
Vertex’s Kaftriois an orally administered medicine. The drug is already approved in the EU in patients aged six years and older for the same indication. Kaftrio is also approved in the United States under the brand name Trikafta to treat CF in people aged two years and older who have at least one F508del mutation.
Besides EU and the United States, Trikaftais approved by regulatory authorities in Great Britain, Australia and Canada, for people with CF aged six and above.
Shares of Vertex have risen 20.9% year to date against the industry’s 14.0% decline.
Image Source: Zacks Investment Research
VRTX enjoys a dominant position in the CF market. Trikafta/ Kaftrio generated revenues of $4.34 billion in the first half of 2023, accounting for almost 89% of the company’s total revenues. The label extension of the drug will expand its targeted patient population as more than 12,000 children will be eligible for the drug. This will likely result in increased sales of the drug in the upcoming quarters.
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. The company 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. Vertex believes exa-cel has the potential to be a one-time functional cure for SCD and TDT patients with an estimated patient population of approximately 32,000.
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 & Stocks to Consider
Vertex currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the same industry are Anika Therapeutics (ANIK - Free Report) and Annovis Bio (ANVS - Free Report) , both 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 Zacks Consensus Estimate forAnika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.24 for 2023. The bottom-line estimate has widened from a loss of 79 cents to a loss of 82 cents for 2024 during the same time frame. Shares of the company have lost 41.0% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to a loss of $2.77 for 2024 during the same time frame. Shares of the company have lost 21.0% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.