2:18 PM
Dec 26, 2018
 |  BC Extra  |  Company News

FDA accepts Acer, Kala NDAs before funding lapse

Editor's Note: This article was updated on Dec 28, 2018 at 3:04 PM PST

FDA accepted for review NDAs from Acer Therapeutics Inc. (NASDAQ:ACER) and Kala Pharmaceuticals Inc. (NASDAQ:KALA) before the partial government shutdown blocked the agency from taking on new user fee-based applications.

The agency granted Priority Review to Acer's Edsivo celiprolol (ACER-002) to treat vascular Ehlers-Danlos syndrome (vEDS), a collagen production disorder. Its PDUFA date is June 25. Acer submitted the NDA using pivotal data that it licensed in 2016 from the Greater Paris...

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