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Vertex (VRTX) Gets EU Nod for Kaftrio Use in 2-5 Year Kids
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Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the European Commission (“EC”) has approved its blockbuster cystic fibrosis (“CF”) medicine, Kaftrio, for treating children two to five years old.
The EC has now approved Kaftrio in combination with Kalydeco (ivacaftor) for treating CF in children who have at least one F508del mutation in the CF transmembrane conductance regulator gene. The drug is already approved in the European Union (“EU”) for the same indication in patients aged six years and older.
The latest label expansion nod for Kaftrio by the EC was expected as, in September 2023, the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion for extending the drug’s marketing authorization in the EU in the above mentioned patient population.
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.
Shares of Vertex have rallied 22.3% so far this year against the industry’s decline of 23.2%.
Image Source: Zacks Investment Research
Vertex holds a dominant position in the CF market. Trikafta/Kaftrio generated revenues of $6.61 billion in the first nine months of 2023, accounting for almost 90% of the company’s total product revenues. The label expansion of the drug will expand its targeted patient population as more patients will be eligible for the drug. This will likely result in increased sales of the drug in the fourth quarter.
While CF remains the main area of focus, Vertex is also developing treatments for sickle cell disease (SCD), beta thalassemia (TDT), acute and neuropathic pain, APOL1-mediated kidney disease, type I diabetes and alpha-1 antitrypsin deficiency. It has earlier-stage programs in diseases such as muscular dystrophy.
Vertex has co-developed a gene-editing treatment, Casgevy (exa-cel), in partnership with CRISPR Therapeutics (CRSP - Free Report) , for SCD and TDT. Casgevy was approved for both indications in the United Kingdom in November 2023.
VRTX and CRSP have submitted a regulatory application to the FDA for exa-cel in SCD and TDT indications, with a final decision expected by Dec 8, 2023 (priority review) and Mar 30, 2024, respectively.
Vertex and CRISPR Therapeutics have also made regulatory submissions for exa-cel in the European Union that are currently under review.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 19.4%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.33. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.64. Year to date, shares of LGND have decreased 10.9%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.
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Vertex (VRTX) Gets EU Nod for Kaftrio Use in 2-5 Year Kids
Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced that the European Commission (“EC”) has approved its blockbuster cystic fibrosis (“CF”) medicine, Kaftrio, for treating children two to five years old.
The EC has now approved Kaftrio in combination with Kalydeco (ivacaftor) for treating CF in children who have at least one F508del mutation in the CF transmembrane conductance regulator gene. The drug is already approved in the European Union (“EU”) for the same indication in patients aged six years and older.
The latest label expansion nod for Kaftrio by the EC was expected as, in September 2023, the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion for extending the drug’s marketing authorization in the EU in the above mentioned patient population.
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.
Shares of Vertex have rallied 22.3% so far this year against the industry’s decline of 23.2%.
Vertex holds a dominant position in the CF market. Trikafta/Kaftrio generated revenues of $6.61 billion in the first nine months of 2023, accounting for almost 90% of the company’s total product revenues. The label expansion of the drug will expand its targeted patient population as more patients will be eligible for the drug. This will likely result in increased sales of the drug in the fourth quarter.
While CF remains the main area of focus, Vertex is also developing treatments for sickle cell disease (SCD), beta thalassemia (TDT), acute and neuropathic pain, APOL1-mediated kidney disease, type I diabetes and alpha-1 antitrypsin deficiency. It has earlier-stage programs in diseases such as muscular dystrophy.
Vertex has co-developed a gene-editing treatment, Casgevy (exa-cel), in partnership with CRISPR Therapeutics (CRSP - Free Report) , for SCD and TDT. Casgevy was approved for both indications in the United Kingdom in November 2023.
VRTX and CRSP have submitted a regulatory application to the FDA for exa-cel in SCD and TDT indications, with a final decision expected by Dec 8, 2023 (priority review) and Mar 30, 2024, respectively.
Vertex and CRISPR Therapeutics have also made regulatory submissions for exa-cel in the European Union that are currently under review.
Zacks Rank & Stocks to Consider
Vertex currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CytomX Therapeutics, Inc. (CTMX - Free Report) and Ligand Pharmaceuticals Incorporated (LGND - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CytomX Therapeutics’ 2023 loss per share have narrowed from 37 cents to 10 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 51 cents to 22 cents. Year to date, shares of CTMX have lost 19.4%.
Earnings of CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter average earnings surprise of 45.44%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.33. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.64. Year to date, shares of LGND have decreased 10.9%.
Earnings of Ligand Pharmaceuticals beat estimates in each of the trailing four quarters. On average, LGND came up with a four-quarter earnings surprise of 67.19%.