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Biotech Stocks Facing FDA Decision In May 2019

Regeneron Pharmaceuticals
Regeneron Pharmaceuticals

The FDA decision on the expanded indication of Regeneron Pharmaceuticals Inc.’s (REGN) EYLEA for the treatment of patients with diabetic retinopathy without diabetic macular edema is expected on May 13, 2019.

EYLEA, administered as a 2 mg intravitreal injection, is already approved to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy in patients with DME.

Regeneron records net product sales of EYLEA in the United States. Outside the United States, EYLEA net product sales comprise sales by Bayer in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan.

EYLEA brought home sales of $4.07 billion for Regeneron in 2018, up from $3.70 billion in 2017. The global net sales of EYLEA were $6.75 billion in 2018 compared to $5.93 billion in 2017.

REGN closed Thursday’s trading at $349.99, up 2.80%.