Dupixent Gains U.S. Approval for Young Children with Chronic Spontaneous Urticaria
REGN sits 56% above its 52-week low of $476.487.
Summary
The U.S. FDA has approved Dupixent (dupilumab) for children aged 2 to 11 years with uncontrolled chronic spontaneous urticaria (CSU), establishing it as the first biologic medicine for this underserved patient population. This follows the recent European Union approval for the same indication on April 13, further expanding the market for Regeneron's blockbuster drug. This label expansion is a significant positive development, opening a new revenue stream by addressing an unmet medical need for over 14,000 children in the U.S. and reinforcing Dupixent's growth trajectory and market leadership in type 2 inflammatory conditions.
At the time of this announcement, REGN was trading at $744.42 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $78.9B. The 52-week trading range was $476.49 to $821.11. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.