Sanofi (SNY) and Regeneron's Dupixent Recommended for EU Approval

Sanofi (NASDAQ:SNY) is one of the best cheap stocks under $50 to buy right now. On February 27, Sanofi (NASDAQ:SNY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the approval of Dupixent in the EU to treat chronic spontaneous urticaria. Management reported that the recommendation covers children aged two to 11 years with moderate-to-severe CSU, an inadequate response to histamine-1 antihistamines, and who are naïve to anti-immunoglobulin E therapy for CSU. A final decision is anticipated in the coming months.

Sanofi (NASDAQ:SNY) further reported that data from the LIBERTY-CUPID clinical study program support the positive CHMP opinion in young children, including two phase 3 studies in which children aged six to 11 years participated, and the single-arm, CUPIDKids phase 3 study in children aged two to 11 years with CSU. Dupixent holds approval for CSU in certain adults and adolescents in several jurisdictions, including Japan, the EU, and the US. In addition, a supplemental biologics license application has been accepted for review in the United States, seeking approval for Dupixent in certain children aged two to 11 years with CSU, with a decision by the US Food and Drug Administration expected by April 2026.

Sanofi (NASDAQ:SNY) researches, produces, and distributes pharmaceutical products. The company’s operations are divided into the Pharmaceuticals, Consumer Healthcare, and Vaccines segments.