Press Release: Sanofi and Regeneron’s Dupixent recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment
Summary
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU) in children aged two to 11 years in the EU. This recommendation, if approved, would make Dupixent the first targeted medicine for this specific pediatric population with inadequately controlled CSU. This development is a positive step for Regeneron, as Dupixent is a key revenue driver for the company, as noted in its recent 10-K filing. Expanding the drug's label to new indications and patient populations contributes to its continued growth trajectory. Investors should watch for the final decision from the European Commission in the coming months, as well as the anticipated US FDA decision for the same indication by April 2026.
At the time of this announcement, REGN was trading at $768.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $81.5B. 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.