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Roth Capital Reaffirms Regeneron (REGN) at 'Buy'; Dupilumab BLA in AD Key Next Step in Development

Go back to Roth Capital Reaffirms Regeneron (REGN) at 'Buy'; Dupilumab BLA in AD Key Next Step in Development

Regeneron (REGN), Sanofi (SNY) Announce Dupilumab BLA Accepted for Priority Review by FDA

September 26, 2016 6:18 AM EDT

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) and Sanofi (NYSE: SNY) announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), a serious, chronic inflammatory skin disease. The application has been given a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2017. The... More

Sanofi may win U.S. approval of $3 billion eczema drug by March

September 26, 2016 3:26 AM EDT

(Reuters) - French drugmaker Sanofi  and its U.S. partner Regeneron Pharmaceuticals (NASDAQ: REGN) could win U.S. approval for their keenly awaited new eczema drug dupilumab, seen by analysts as a potential $3 billion-a-year seller, by next March.

Sanofi... More