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Sanofi's (SNY) Hemophilia A Candidate Meets Study Endpoints
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Sanofi (SNY - Free Report) and its partner, Swedish Orphan Biovitrum (Sobi), announced that the phase III study — XTEND-1 — evaluating their investigational factor VIII replacement therapy for treating hemophilia A, efanesoctocog alfa, met its primary as well as secondary endpoints.
The XTEND-1 study was evaluating efanesoctocog alfa in severe hemophilia A patients aged 12 years of age or older previously treated with a currently approved factor VIII replacement therapy.
Data from the late-stage study demonstrated that weekly prophylaxis with the candidate for one year achieved clinically meaningful prevention of bleeds in people with severe hemophilia A, XTEND-1’s primary endpoint. The candidate achieved a median annualized bleeding rate (“ABR”) of 0 and a mean ABR of 0.71 in the study.
The data also showed that efanesoctocog alfa demonstrated superiority to prior factor prophylaxis treatment, the study’s secondary endpoint. The candidate also achieved near-normal factor activity levels for the majority of the week when administered once a week as prophylactic treatment.
Data from XTEND-1 will support regulatory application submission across the globe, starting this year. A European regulatory application will be filed in 2023, following the availability of data from an ongoing pediatric study — XTEND-Kids.
Sanofi’s shares have gained 3.6% so far this year against the industry’s decrease of 5%.
Image Source: Zacks Investment Research
We note that there are several approved replacement therapies for hemophilia A available in the market including Roche’s (RHHBY - Free Report) Hemlibra. Several pharma/biotech companies are developing novel gene therapies targeting the inherited disorder, which includes Roche, BioMarin (BMRN - Free Report) and Pfizer (PFE - Free Report) .
Roche is developing a factor VIII gene transfer treatment for hemophilia A in a phase I/II study. Roche added the investigation of the hemophilia gene therapy with the acquisition of Spark Therapeutics in 2019.
BioMarin has developed a gene therapy, valoctocogene roxaparvovec, for severe hemophilia A. BioMarin is currently seeking approval for the candidate in Europe. BioMarin plans to resubmit a biologics license application (“BLA”) for the candidate to the FDA by BioMarin in the second quarter of 2022. The FDA had issued a complete response letter in August 2020 to the BLA that was accepted for priority review in February that year.
Pfizer is developing its gene therapy candidate, giroctocogene fitelparvovec, targeting hemophilia A patients. Pfizer is currently evaluating the candidate in a phase III study in adult males. Pfizer is developing the gene therapy candidate in partnership with Sangamo Therapeutics.
Image: Bigstock
Sanofi's (SNY) Hemophilia A Candidate Meets Study Endpoints
Sanofi (SNY - Free Report) and its partner, Swedish Orphan Biovitrum (Sobi), announced that the phase III study — XTEND-1 — evaluating their investigational factor VIII replacement therapy for treating hemophilia A, efanesoctocog alfa, met its primary as well as secondary endpoints.
The XTEND-1 study was evaluating efanesoctocog alfa in severe hemophilia A patients aged 12 years of age or older previously treated with a currently approved factor VIII replacement therapy.
Data from the late-stage study demonstrated that weekly prophylaxis with the candidate for one year achieved clinically meaningful prevention of bleeds in people with severe hemophilia A, XTEND-1’s primary endpoint. The candidate achieved a median annualized bleeding rate (“ABR”) of 0 and a mean ABR of 0.71 in the study.
The data also showed that efanesoctocog alfa demonstrated superiority to prior factor prophylaxis treatment, the study’s secondary endpoint. The candidate also achieved near-normal factor activity levels for the majority of the week when administered once a week as prophylactic treatment.
Data from XTEND-1 will support regulatory application submission across the globe, starting this year. A European regulatory application will be filed in 2023, following the availability of data from an ongoing pediatric study — XTEND-Kids.
Sanofi’s shares have gained 3.6% so far this year against the industry’s decrease of 5%.
Image Source: Zacks Investment Research
We note that there are several approved replacement therapies for hemophilia A available in the market including Roche’s (RHHBY - Free Report) Hemlibra. Several pharma/biotech companies are developing novel gene therapies targeting the inherited disorder, which includes Roche, BioMarin (BMRN - Free Report) and Pfizer (PFE - Free Report) .
Roche is developing a factor VIII gene transfer treatment for hemophilia A in a phase I/II study. Roche added the investigation of the hemophilia gene therapy with the acquisition of Spark Therapeutics in 2019.
BioMarin has developed a gene therapy, valoctocogene roxaparvovec, for severe hemophilia A. BioMarin is currently seeking approval for the candidate in Europe. BioMarin plans to resubmit a biologics license application (“BLA”) for the candidate to the FDA by BioMarin in the second quarter of 2022. The FDA had issued a complete response letter in August 2020 to the BLA that was accepted for priority review in February that year.
Pfizer is developing its gene therapy candidate, giroctocogene fitelparvovec, targeting hemophilia A patients. Pfizer is currently evaluating the candidate in a phase III study in adult males. Pfizer is developing the gene therapy candidate in partnership with Sangamo Therapeutics.
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