FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
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sanofi.com/en/investors
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Source: Yahoo! Finance
Dupixent is a key top-line driver for both Sanofi and Regeneron, with strong demand trends. In the first nine months of 2024, Dupixent generated global product sales of €9.6 billion, representing growth of 25.9% at a constant exchange rate. Sanofi expects Dupixent to achieve more than €13 billion in sales in 2024. (Source: Sanofi's financial reports) Estimates for Gilead's 2024 earnings have risen from $3.77 to $4.28 per share over the past 60 days, while Pfizer's earnings estimates have risen from $2.66 to $2.88 per share for 2024. Gilead beat estimates in three of the last four reported quarters, while Pfizer beat estimates in each of the last four quarters. (Source: Zacks Investment Research) The FDA has accepted the resubmitted sBLA, which seeks approval of Dupixent for the treatment of CSU in people aged 12 years and older whose disease is not adequately controlled with existing therapies like H1 antihistamines. The FDA's decision on the sBLA is expected on April 18, 2025. (
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