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Sanofi withdraws Dupixent application in Europe following concerns from the European Medicines Agency.

MarketRead the original at benzinga.com
Neutral

Withdrawal of Dupixent's regulatory application in Europe for bullous pemphigoid due to insufficient efficacy.

SNY · Sanofi SA

AI read · Neutral

The AI's read

Sanofi withdrew its EU application for Dupixent in bullous pemphigoid after the EMA found the core trial missed its primary endpoint and supporting data were weak. That cuts a potential new label and raises regulatory risk for the program. The news is new and not fully priced in. SNY is up 1.37% today, so markets are shrugging rather than pricing a deep hit. We lean bearish because the removal limits near-term upside for Dupixent in Europe and forces bigger evidence demands going forward. Conviction 90% given explicit EMA conclusions and no countervailing market rally.

REGN · Regeneron Pharmaceuticals Inc.

AI read · Bad for REGN

The connection

Potential negative impact on Regeneron's partnership with Sanofi regarding Dupixent's market prospects.

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