BioCentury
ARTICLE | Company News

FDA setback, positive data for Regeneron’s Eylea

October 26, 2018 12:23 AM UTC

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) shares slipped on Thursday, falling $14.45 to $336.94, after the company reported a regulatory delay for a prefilled syringe of Eylea aflibercept alongside positive data for the eye drug.

The company said it received a complete response letter from FDA for the prefilled syringe requesting additional manufacturing information and completion of a usability study in 30 patients. Regeneron still expects to launch in 2019. ...

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Regeneron Pharmaceuticals Inc.