FDA Accepts Dupixent's Priority Review for Bullous Pemphigoid

The FDA has granted Priority Review to Dupixent for treating bullous pemphigoid. If approved, it will be the first targeted therapy for this skin disease, which could positively impact Regeneron and Sanofi's stock. The decision is expected by June 2025.

Date: 18-02-2025

AI Rating: 7

**Earnings Impact from FDA Decision**
Dupixent's acceptance for Priority Review by the FDA is a promising development for both Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY). If approved, this would introduce a groundbreaking treatment into the market, potentially leading to increased revenue and net income as it gains traction in the classified niche market of bullous pemphigoid. The dual approach may lead to a favorable shift in profit margins and earnings per share as a result of addressing a rare disease, which previously lacked targeted therapies.

Moreover, the priority review indicates a positive outlook, as it is granted to therapies providing significant improvements for severe diseases. This capitalizes on the growing demand for targeted treatments. Regulatory approvals in over 60 countries already demonstrate a strong acceptance pattern for Dupixent, which can yield a significant revenue stream across various indications. This cumulative impact adds to the investor confidence in REGN and SNY, potentially reflecting positively on their EPS and FCF in the medium to long term.

As the FDA's decision on Dupixent is set for June 20, 2025, market speculation will likely amplify, influencing stock price volatility leading up to this date. The focus on Phase 3 trials for Dupixent in various diseases also suggests a robust pipeline which enhances investor sentiment. Overall, all these factors combine to present a favorable outlook for both Regeneron and Sanofi following the FDA's decision.

Stocks: REGN SNY