Xspray received a CRL from the FDA for its Nilopki NDA ahead of the June 18 PDUFA date. The CRL itself was not out of the blue with the agency citing three deficiencies, of which one was anticipated. A Class 2 resubmission appears as the probable outlook for Nilopki, pointing to a new PDUFA date in H1 2027. This development increases tension on the outcome of the pre-approval inspections of Xspray's CDMO, which remains the major near-term catalyst.
LÄS MER
