2023-03-25 08:43:00 ET
Recently, Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) received positive news from the U.S. Food and Drug Administration (FDA). The agency accepted Dupixent's supplemental Biologics License Application for review to treat adult patients with chronic spontaneous urticaria (CSU), a skin disorder.
With a decision expected from the FDA by October of this year, patients with CSU could have a much-needed treatment available by the end of the year. But how much of a sales lift could such an approval provide for Sanofi? Let's assess the phase 3 clinical trial results and the U.S. CSU market to lay this question to rest.
CSU is an inflammatory skin condition, which results in sudden and severe hives and skin swelling. Patients typically experience swelling (also known as angioedema) on the face, hands, and feet, but the throat and upper airways can also be affected by the condition.
For further details see:
Could This Label Expansion Be a Growth Catalyst for Sanofi Stock?