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June 11, 2014
05:36 EDTBAYRY, REGNRegeneron, Bayer submit Eylea Injection for EU marketing authorization
Regeneron Pharmaceuticals (REGN) and Bayer HealthCare (BAYRY) announced that Bayer HealthCare has submitted an application to the European Medicines Agency seeking marketing authorization in the European Union for Eylea Injection for the treatment of macular edema following branch retinal vein occlusion, or BRVO. The EMA submission is based on the positive Phase 3 VIBRANT trial, a double-masked, randomized, active-controlled study of patients with macular edema following BRVO. In the VIBRANT study, 53% of patients who received EYLEA 2 milligram monthly gained at least 15 letters in best-corrected visual acuity, or BCVA, from baseline at week 24, the primary endpoint of the study, compared to 27 of patients who received laser, a standard of care treatment. In addition, EYLEA met a key secondary endpoint, achieving a 17.0 letter mean improvement over baseline in BCVA compared to a 6.9 letter mean improvement in patients who received laser.
News For REGN;BAYRY From The Last 14 Days
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April 16, 2015
12:19 EDTBAYRYBayer downgraded to Equal Weight from Overweight at Morgan Stanley
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April 15, 2015
07:41 EDTBAYRYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 10, 2015
07:17 EDTREGNExpert very bullish on outlook for Regeneron Eylea, says RBC Capital
RBC Capital reports that a retina expert with whom it spoke was "very bullish" on the outlook for Regeneron's Eylea, not just in DME but also in wet AMD. The firm says the expert's positive outlook was sparked by recently presented Protocol T data. RBC continues to believe that Eylea could beat guidance this year, while Phase III programs could boost the stock. RBC keeps a $490 price target and Outperform rating on the shares.

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