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Investing.com - Leerink Partners has reiterated an Outperform rating on Sanofi (NASDAQ:SNY), the $101.4 billion pharmaceutical giant currently trading at $90.63, following the company’s announcement of topline results from its Phase 3 COAST-1 trial evaluating amlitelimab in atopic dermatitis. According to InvestingPro, the company maintains a GOOD financial health score, suggesting strong operational stability.
The trial met its primary and secondary endpoints at Week 24 for both the subcutaneous Q4W (every 4 weeks) and Q12W (every 12 weeks) dosing arms. However, the treatment efficacy was notably inferior to Sanofi and Regeneron’s Dupixent performance at Week 16, which had been considered the benchmark for compelling results. The stock has shown strong momentum this year, with a 37.23% year-to-date return, reflecting investor confidence despite mixed trial results.
Placebo-adjusted EASI-75 responses were 17% and 20% for the Q4W and Q12W arms respectively, while placebo-adjusted vIGA-AD 0/1 responses were 12% and 13%. These results represent a significant decrease in efficacy compared to the Phase 2b trial and fall short of Dupixent’s performance in Phase 3 SOLO trials, where placebo-adjusted EASI-75 reached 32-34% and vIGA-AD 0/1 was 28%.
Despite underwhelming efficacy, Leerink suggests amlitelimab could potentially find a role in second-line treatment settings, particularly given its novel mechanism of action and convenient Q12W dosing. The safety profile was favorable with low rates of pyrexion and chills.
Sanofi plans to present full Phase 3 COAST-1 results at an upcoming medical meeting, with several other amlitelimab trials expected to report results through 2026, including the Phase 3 SHORE trial with estimated primary completion in August 2025. Investors following this development should note that Sanofi’s next earnings report is scheduled for October 28, 2025. For deeper insights into Sanofi’s financial metrics and growth potential, check out the comprehensive research report available on InvestingPro.
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