PolyPid Ltd. (NASDAQ: PYPD) announced it has completed its New Drug Application submission to the U.S. Food and Drug Administration for D-PLEX100, a drug candidate designed to prevent surgical site infections in patients undergoing colorectal surgery.

The company submitted the application on a rolling review basis and expects a potential FDA decision in the first quarter of 2027 under the Prescription Drug User Fee Act review timeline.

The application is supported by results from the company's Phase 3 SHIELD II trial, which met its primary endpoint and demonstrated a 60% relative risk reduction in surgical site infections compared to standard of care with a p-value of 0.0013.

D-PLEX100 has received Breakthrough Therapy, Fast Track, and Qualified Infectious Disease Product designations from the FDA, making it eligible for Priority Review. The drug is administered locally at the surgical site during wound closure and delivers sustained, controlled release of doxycycline for approximately 30 days.

"Completing the NDA submission for D-PLEX100 is a defining milestone for PolyPid and the culmination of years of disciplined clinical and regulatory work," said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid.

The drug is built on the company's proprietary Kynatrix technology platform. PolyPid is based in Petach Tikva, Israel, and focuses on developing long-acting, controlled-release drugs for delivery at the site of care.