SNY and REGN’s Dupixent sBLA for Skin Disease Gets FDA’s Priority Tag – February 18, 2025

From Zacks Investment Research.: 2025-02-18 08:52:09

Sanofi and Regeneron have submitted a supplemental biologics license application (sBLA) to the FDA for Dupixent to treat bullous pemphigoid, with a decision expected by June 20, 2025. The sBLA is based on a study showing Dupixent’s efficacy in adult patients with moderate-to-severe BP. Dupixent is already approved in several countries for multiple inflammatory diseases and is a key driver for both companies. Sanofi expects Dupixent to achieve around €22 billion in sales by 2030. Gilead and Alnylam are top-ranked drug/biotech companies to watch, with positive earnings estimates and strong stock performance.



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