Europe Approves Sanofi's Enjaymo For Rare Form Of Anemia - Sanofi (NASDAQ:SNY)

The European Commission has approved Sanofi SA SNY Enjaymo (sutimlimab) for hemolytic anemia in adult patients with cold agglutinin disease (CAD).
CAD is a rare chronic autoimmune hemolytic anemia, where the body's immune system mistakenly attacks healthy red blood cells, rupturing them (hemolysis).
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Enjaymo is currently the only approved treatment for CAD. It is a first-in-class humanized monoclonal antibody designed to selectively target and inhibit the classical complement pathway-specific serine protease, C1s.
The approval is based on data from two Phase 3 trials - CADENZA and CARDINAL.
In the CADENZA Part A study, Enjaymo met its primary composite endpoint and all secondary endpoints. It demonstrated hemolysis inhibition, hemoglobin levels increase, and clinically meaningful improvement in Fatigue scores.
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Price Action: SNY shares are up 0.18% at $43.94 on the last check Thursday.