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Regeneron and Sanofi Report Positive Phase 2/3 Dupixent Results

Regeneron and Sanofi present promising results from a trial on Dupixent for bullous pemphigoid. The findings indicate significant efficacy, which could positively influence their stock prices.

Date: 
AI Rating:   7

Positive Trial Results: Regeneron Pharmaceuticals Inc. (REGN) and Sanofi reported successful results from the ADEPT Phase 2/3 trial for Dupixent in treating moderate-to-severe bullous pemphigoid. With a substantial percentage of patients achieving sustained disease remission, the efficacy of Dupixent significantly outperformed placebo.

Improved Patient Outcomes: The trial showed that 20% of patients on Dupixent experienced sustained disease remission, compared to only 4% on placebo. Additionally, 40% achieved a 90% reduction in disease severity, suggesting a robust therapeutic benefit that may attract more prescribers and patients. Such outcomes are likely to boost investor confidence.

Regulatory Progress: The FDA has accepted the supplemental Biologics License Application for Dupixent to treat bullous pemphigoid and is expected to issue a decision by June 20, 2025. Regulatory approvals can often lead to stock price boosts, especially when they stem from successful trial results, as seen here.

Market Potential: Previously granted Orphan Drug Designation implies rare disease status, which can allow for higher pricing and less competition, translating into potential revenue growth for REGN and Sanofi if approved.

The report does not provide details on earnings per share (EPS), revenue growth, net income, profit margins, free cash flow (FCF), or return on equity (ROE), thus they cannot be analyzed.