Posted by Michael Wonder on 30 Jul 2026
PolyPid announces FDA acceptance of NDA with priority review for D-PLEX₁₀₀
29 July 2026 - PolyPid today announced that the US FDA has accepted for filing the new drug application and granted the NDA a priority review for D-PLEX100 for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
The FDA did not identify any filing review issues and set a PDUFA target action date of 28 November 2026, approximately one quarter ahead of the Company’s previously communicated first quarter 2027 guidance.
