Overview

• COAST 1 met all primary and key secondary endpoints at Week 24 in moderate-to-severe atopic dermatitis patients aged 12 and older versus placebo.
• Sanofi reported EASI-75 responder rates of 35.9% and 46% with every-4-week dosing versus 19.1% on placebo, and 39.1% and 50.3% with every-12-week dosing versus 27.6%.
• Amlitelimab was well tolerated with no new safety concerns, and the regimen includes a potential every-12-week schedule that could mean four doses per year.
• Shares fell about 8% on Thursday as the efficacy trailed results seen in an earlier Phase 2 trial and investor expectations.
• Analysts split on prospects, with some questioning the OX40 pathway after similar setbacks at Amgen, while others point to convenience advantages as Sanofi awaits additional OCEANA Phase 3 readouts through 2026 for potential filings.