SNY & REGN's Dupixent Receives CHMP Backing for Urticaria in EU

Sanofi (SNY) and Regeneron (REGN) received a positive opinion from the European Medicines Agency's CHMP recommending approval of Dupixent for chronic spontaneous urticaria (CSU) in patients aged 12 and above, following its FDA approval for the same indication in April 2025. This pivotal regulatory step, based on strong Phase III data, expands Dupixent's market reach for type II inflammatory diseases and reinforces its position as a key revenue driver, having generated €7.3 billion in global sales in H1 2025 and projected to reach €22 billion by 2030.

Analysis

Sanofi (SNY) and Regeneron (REGN) have secured a significant regulatory milestone with the positive opinion from the European Medicines Agency's CHMP for Dupixent's use in chronic spontaneous urticaria (CSU). This recommendation, which follows the drug's U.S. approval for the same indication in April 2025, is supported by strong Phase III data from the LIBERTY-CUPID program, which demonstrated significant reductions in itch and hives with a consistent safety profile. The expansion into the EU for CSU is critical for sustaining the drug's growth trajectory, which is already a key top-line driver for both companies, having generated €7.3 billion in sales in the first half of 2025, a 20.7% increase at a constant exchange rate. This development reinforces the path toward Sanofi's projection of achieving approximately €22 billion in annual sales for Dupixent by 2030. Notably, this positive news for Sanofi arrives while its stock has underperformed its industry year-to-date, with a 2.5% loss compared to the industry's 0.9% gain.

Key Decisions for Investors

• Investors should consider this positive CHMP opinion a significant de-risking event for Dupixent's long-term sales targets, reinforcing the bull case for both Sanofi and Regeneron.
• Monitor for the final European Commission decision in the coming months, as formal approval will be the next catalyst for realizing revenue from this expanded indication and tracking progress toward the €22 billion 2030 sales projection.
• Given Sanofi's recent share price underperformance, this fundamental catalyst may present a favorable entry point for investors looking to gain exposure to a blockbuster drug with a strengthening market position and a clear growth runway.