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CRISPR (CRSP), Vertex Get UK Nod for First Gene Therapy Casgevy
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CRISPR Therapeutics AG (CRSP - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) announced that the Medicines and Healthcare products Regulatory Agency (“MHRA”) of the United Kingdom has granted conditional marketing authorization to their CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel [exa-cel]) for treating two debilitating blood disorders, sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
The approval makes Casgevy the first approved product in CRISPR Therapeutics’ portfolio.
The MHRA approved Casgevy for the treatment of SCD in patients aged 12 years and above with recurrent vaso-occlusive crises (VOCs). The MHRA also gave its nod to Casgevy for the treatment of TDT in patients aged 12 years and older, for whom a human leukocyte antigen (HLA) matched related hematopoietic stem cell donor is not available.
The approval for Casgevy by the MHRA comes as a major breakthrough for medical science, as it is the first regulatory authorization of a CRISPR-based gene-editing therapy in the entire world.
Casgevy is likely to offer a new treatment option to an estimated 2,000 eligible patients in the United Kingdom.
Shares of CRISPR Therapeutics were up almost 6% in pre-market trading on Thursday following the MHRA approval for Casgevy.
The stock has rallied 38.3% year to date against the industry’s decline of 22.5%.
Image Source: Zacks Investment Research
We remind investors that CRISPR Therapeutics has developed exa-cel for treating SCD and TDT in partnership with Vertex Pharmaceuticals.
CRSP and VRTX’s biologics license application (BLA) submissions seeking approval for exa-cel in SCD and TDT indications are currently under review in the United States.
The FDA granted priority review to the BLA filing for exa-cel in SCD indication, while the exa-cel filing in TDT indication was accepted for a standard review. A final decision on the BLAs for exa-cel in SCD and TDT indications is expected by Dec 8, 2023, and Mar 30, 2024, respectively.
Last month, an FDA advisory committee appeared satisfied with CRISPR/Vertex’s regulatory filing on exa-cel in SCD indication. This likely moves the gene therapy closer to gaining potential marketing approval from the agency.
The companies have filed similar regulatory submissions for exa-cel in Europe, which was validated by the European Medicines Agency in January 2023.
Zacks Rank & Stocks to Consider
CRISPR Therapeutics currently carries a Zacks Rank #2 (Buy).
In the past 60 days, estimates for Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 27.2%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 293.21%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 15.5%.
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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CRISPR (CRSP), Vertex Get UK Nod for First Gene Therapy Casgevy
CRISPR Therapeutics AG (CRSP - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) announced that the Medicines and Healthcare products Regulatory Agency (“MHRA”) of the United Kingdom has granted conditional marketing authorization to their CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel [exa-cel]) for treating two debilitating blood disorders, sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
The approval makes Casgevy the first approved product in CRISPR Therapeutics’ portfolio.
The MHRA approved Casgevy for the treatment of SCD in patients aged 12 years and above with recurrent vaso-occlusive crises (VOCs). The MHRA also gave its nod to Casgevy for the treatment of TDT in patients aged 12 years and older, for whom a human leukocyte antigen (HLA) matched related hematopoietic stem cell donor is not available.
The approval for Casgevy by the MHRA comes as a major breakthrough for medical science, as it is the first regulatory authorization of a CRISPR-based gene-editing therapy in the entire world.
Casgevy is likely to offer a new treatment option to an estimated 2,000 eligible patients in the United Kingdom.
Shares of CRISPR Therapeutics were up almost 6% in pre-market trading on Thursday following the MHRA approval for Casgevy.
The stock has rallied 38.3% year to date against the industry’s decline of 22.5%.
We remind investors that CRISPR Therapeutics has developed exa-cel for treating SCD and TDT in partnership with Vertex Pharmaceuticals.
CRSP and VRTX’s biologics license application (BLA) submissions seeking approval for exa-cel in SCD and TDT indications are currently under review in the United States.
The FDA granted priority review to the BLA filing for exa-cel in SCD indication, while the exa-cel filing in TDT indication was accepted for a standard review. A final decision on the BLAs for exa-cel in SCD and TDT indications is expected by Dec 8, 2023, and Mar 30, 2024, respectively.
Last month, an FDA advisory committee appeared satisfied with CRISPR/Vertex’s regulatory filing on exa-cel in SCD indication. This likely moves the gene therapy closer to gaining potential marketing approval from the agency.
The companies have filed similar regulatory submissions for exa-cel in Europe, which was validated by the European Medicines Agency in January 2023.
Zacks Rank & Stocks to Consider
CRISPR Therapeutics currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the healthcare sector are Dynavax Technologies Corporation (DVAX - Free Report) and Ligand Pharmaceuticals Incorporated , 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 Dynavax Technologies’ 2023 loss per share have narrowed from 24 cents to 12 cents. Meanwhile, during the same period, earnings per share estimates for 2024 have improved from 2 cents to 18 cents. Year to date, shares of DVAX have rallied 27.2%.
Earnings of Dynavax Technologies beat estimates in two of the last four quarters while missing the same on the remaining two occasions. DVAX delivered a four-quarter average earnings surprise of 293.21%.
In the past 60 days, Ligand Pharmaceuticals’ earnings per share estimates for 2023 have improved from $4.98 to $5.10. During the same period, earnings per share estimates for 2024 have moved up from $4.26 to $4.59. Year to date, shares of LGND have lost 15.5%.
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%.