Shares of Regeneron Pharmaceuticals, Inc. (REGN) have been riding high after the company announced that its supplemental biologics license application (sBLA) for eye drug Eylea will be reviewed by the FDA on a priority basis. Shares of the company hit a 52-week high of $425.28 on Dec 3, eventually closing a little lower at $424.41. The stock has amassed a year-to-date return of 54.6%.
Eylea Priority Review Status
Earlier this week, the FDA accepted for priority review the sBLA for Eylea. Regeneron is looking to get Eylea’s label expanded to include diabetic retinopathy in patients with diabetic macular edema (DME). A final decision from the FDA is expected by Mar 30, 2015 (read more: Regeneron/Bayer's Eylea to be Reviewed on a Priority Basis).
Eylea is already approved in the U.S. for the treatment of wet age-related macular degeneration, macular edema following retinal vein occlusion and DME. Eylea revenues were $722 million in the third quarter of 2014, up 48% from the year-ago period.
Regeneron holds rights to Eylea within the U.S, while the HealthCare segment of Bayer (BAYRY) holds the commercialization rights for the product in the ex-U.S. markets. Regeneron and Bayer equally share the profits from Eylea sales in all ex-U.S. territories except Japan, where Regeneron receives royalties on Eylea’s net sales.
Regeneron’s primary growth driver Eylea is expected to continue performing well. We believe that the prospective expansion of Eylea’s label would boost its sales potential significantly.
Regeneron carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Amgen Inc. (AMGN) and AMAG Pharmaceuticals, Inc. (AMAG). While Amgen carries a Zacks Rank #1 (Strong Buy), AMAG Pharma carries a Zacks Rank #2 (Buy).
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