Regeneron's (REGN) Eylea sBLA Receives Priority Review as DME + Diabetic Retinopathy Treatment; Roth Capital Comments

Roth Capital affirms Regeneron (Nasdaq: REGN) at Buy with a price target of $461 following news that the U.S. FDA accepted the Priority Review sBLA application for Eylea for treatment of patients with diabetic retinopathy coupled with DME.

Analyst Joseph Pantginis commented, We continue to be impressed with the progress made with Eylea on the commercial and clinical development sides. We believe there is high likelihood of approval for DR-DME, which should further contribute to Eylea's revenue growth. With recent FDA approvals for RVO (CRVO and BRVO) we look forward to 4Q14 results to see the impact on sales growth. While we are vigilant following management's note of potential slower uptake of Eylea in these newly approved indications due to RVO progression dynamics compared to wet AMD, we believe that long-term there is room for growth, supported by the successful clinical studies and expanding literature.

With regards to the other clinical programs, we look forward to several catalysts from the advanced stage antibody programs. REGN and SNY expect to submit U.S. and EU regulatory filings for alirocumab by the end of the year, using their Priority Review voucher.

Recall that, to date, the 10 published Phase III ODYSSEY studies of alirocumab have achieved their endpoints. The Phase IIb study of dupilumab in asthma is fully enrolled and data is expected by the end of 2014. Additionally, dupilumab is in a newly initiated Phase III in atopic dermatitis. Sarilumab, is currently in a Phase III study for rheumatoid arthritis. REGN expects to initiate an additional Phase III study, MONARCH, comparing sarilumab against adalimumab (Humira)(NYSE: ABBV) by the end of the year.

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Regeneron Pharma closed at $416.11 yesterday.

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