Regeneron receives FDA approval for EYLEA for treatment of DME Regeneron Pharmaceuticals announced that the FDA has approved EYLEA Injection for the treatment of Diabetic Macular Edema, or DME. The approval of EYLEA in DME was based on the one-year data from the phase 3 VISTA-DME and VIVID-DME studies of 862 patients. In Europe, the Committee for Medicinal Products for Human Use has given a positive opinion recommending approval for EYLEA in the treatment of DME. Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME. In Japan, EYLEA has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia. A regulatory submission has been made in the U.S. and Europe for EYLEA for the treatment of Macular Edema following Branch Retinal Vein Occlusion.
On The Fly: Analyst Initiation Summary Today's noteworthy initiations include: Adeptus Health (ADPT) initiated with a Buy at Dougherty... Amphastar (AMPH) initiated with a Buy at Jefferies... Eclipse Resources (ECR) initiated with a Neutral at SunTrust... Fidelity National (FNF) initiated with a Buy at SunTrust... First American (FAF) initiated with a Buy at SunTrust... GoPro (GPRO) initiated with a Hold at Stifel... Imprivata (IMPR) initiated with an Outperform at Wells Fargo... Lifetime Brands (LCUT) initiated with a Buy at Sidoti... Materialise (MTLS) initiated with a Buy at BB&T... Regeneron (REGN) initiated with a Buy at Argus... STAG Industrial (STAG) initiated with a Buy at Sandler O'Neill... Signature Group (SGGH) initiated with a Buy at B. Riley... TCP International (TCPI) initiated with a Buy at Canaccord... Tessera (TSRA) initiated with a Buy at Craig-Hallum... Xunlei (XNET) initiated with a Perform at Oppenheimer.