Regeneron Shares Fall on FDA Delay

Xconomy New York — 

Shares of Tarrytown, NY-based Regeneron (NASDAQ: REGN) were down 4 percent in morning trading to $54.95 on news that the FDA has delayed its decision on the company’s macular degeneration drug by three months. The company had initially expected to hear by August 20 if the drug, called aflibercept (Eyelea), would be approved. But the FDA classified Regeneron’s recent responses to questions regarding the chemistry, manufacturing, and controls as a “major amendment” to the original approval application, according to a press release, and extended the date for a decision to November 18. The drug addresses a multibillion-dollar market and thus is expected to be Regeneron’s first major foray into the commercial pharmaceutical market.