Roth Capital Reaffirms Regeneron (REGN) at 'Buy'; Dupilumab BLA in AD Key Next Step in Development
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Roth Capital affirms Regeneron Pharma (Nasdaq: REGN) with a Buy rating and $520 price target after the company and Sanofi 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)
Analyst Joseph Pantginis commented,
This is an important next step for dupilumab and we expect full approval of the product. A key upcoming catalyst is the Oct. 30 PDUFA date for sarilumab in RA patients, where we also expect full approval. With the recent partnership for fasimumab with TEVA (NC), we believe that REGN's pipeline positioning continues to improve with near term potential approvals of potential blockbuster drugs supported by Eylea revenue and continued blocking and tackling for Praluent (prescription trends below). We believe the inflection point for Praluent sales will be Phase III outcomes data ultimately, but the scripts continue to point in the right direction, in our belief. The IDMC interim analysis for the Praluent ODYSSEY OUTCOMES study is expected this year. In the U.S. the sBLA for the 300-milligram monthly dose of Praluent has been issued a PDUFA date of January 24th, 2017. A regulatory application for Praluent monthly dosing in the E.U. has also been submitted. Furthermore, in July 2016 use of Praluent was approved in Japan.
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Create E-mail Alert Related CategoriesAnalyst Comments, FDA
Related EntitiesRoth Capital, PDUFA
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