SNY/REGN—FDA accepts resubmitted Kevzara (sarilumab) BLA for review: https://globenewswire.com/news-release/2017/04/28/974036/0/en/Sanofi-and-Regeneron-Announce-Kevzara-sarilumab-Biologics-License-Application-Resubmission-Accepted-for-Review-by-US-FDA.html The new PDUFA date is 5/22/17 (i.e. this a Class-1 response). The original BLA submission received a CRL for CMC issues (#msg-126139243, #msg-126123492).