The FDA did not identify any filing review issues and set a Prescription Drug User Fee Act ("PDUFA") target action date of November 28, 2026, approximately one quarter ahead of the Company’s previously communicated first quarter 2027 guidance. Priority Review shortens the FDA’s target review timeline from ten months to approximately six months.

"The FDA’s acceptance of our NDA with Priority Review, arriving with no filing review issues and an accelerated action date, is a defining regulatory milestone for PolyPid in our development of D-PLEX100 as a potential new option to patients for the prevention of surgical site infections, pending the outcome of FDA’s review," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. "We believe this outcome reflects the quality of our regulatory submission and the rigor of our development program for D-PLEX100. Together with our commercial partner Azurity, we are fully aligned on supporting the Agency’s review, and on bringing D-PLEX100, if approved, as a new option to patients for the prevention of SSIs following abdominal colorectal surgery."

The FDA’s acceptance of the NDA triggers a $15 million milestone payment from Azurity Pharmaceuticals ("Azurity"), completing the $30 million in upfront and near-term milestone payments previously announced under the exclusive commercial partnership signed on July 17, 2026.

The Company will continue to support the FDA’s review of the NDA through the November 28, 2026 PDUFA action date, ahead of a potential U.S. commercial launch of D-PLEX100 by Azurity in early 2027.