Sanofi (SNY) Gets Breakthrough Therapy Tag for Hemophilia A Drug
Sanofi SNY announced that the FDA has granted Breakthrough Therapy designation to its novel recombinant factor VIII therapy, efanesoctocog alfa (BIVV001), for the treatment of people with hemophilia A.
A Breakthrough Therapy status is granted to medicines being evaluated for serious conditions where early clinical evidence indicates said medicines’ potential for substantial improvement over available therapies.
The Breakthrough Therapy tag was granted based on data from the phase III XTEND-1 study that evaluated efanesoctocog alfa for the treatment of hemophilia A, a rare and fatal bleeding disorder.
Sanofi is collaborating with Swedish Orphan Biovitrum (Sobi) for the development and commercialization of efanesoctocog alfa.
In March 2022, Sanofi and Sobi announced that the phase III study, XTEND-1, investigating efanesoctocog alfa for treating hemophilia A, met its primary as well as secondary endpoints.
Data from the XTEND-1 study will support regulatory application submissions across the globe, including the FDA, in mid-2022. 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 6.2% so far this year compared with the industry’s increase of 5.3%.
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Several approved replacement therapies for hemophilia A are available in the market, including Roche’s RHHBY Hemlibra.
RHHBY has seen strong uptake for Hemlibra since its launch.
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.
Several pharma/biotech companies like Roche, BioMarin and Pfizer are also developing novel gene therapies targeting the inherited disorder.
Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Leap Therapeutics, Inc. LPTX and Aeglea BioTherapeutics, Inc. AGLE, both carrying Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
AegleaBio Therapeutics’ loss per share estimates narrowed 19.4% for 2022 and 30.2% for 2023 in the past 60 days.
Earnings of AegleaBio Therapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average.
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