FDA accepts Acer, Kala NDAs before funding lapse

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 University Hospitals system. An Acer spokesperson told BioCentury the company expects FDA to review the application under its 505(b)2 pathway. Edsivo is repurposed celiprolol, a cardioselective adrenergic receptor β 1 (ADRB1) antagonist...