Sanofi’s (SNY) Biologics License Application for Sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease is under priority review by the FDA, with a decision expected on November 13, 2020.Cold Agglutinin Disease, or CAD in short, is a chronic autoimmune hemolytic anemia that causes the body’s immune system to mistakenly attack healthy red blood cells and cause their rupture (hemolysis). CAD patients may experience chronic anemia, profound fatigue, acute hemolytic crisis, and other potential complications, including an increased risk of thromboembolic events and early death.It is estimated that about 5,000 people in the U.S. have CAD.Sutimlimab is designed to selectively target and inhibit Complement Component C1s that plays a major role in innate immunity.If approved, Sutimlimab would be the first and only approved treatment for hemolysis in adult patients with Cold Agglutinin Disease, with peak sales estimated at $200 million.SNY closed Friday’s (Oct.23, 2020) trading at $49.33, up 0.82%.