EMA validates PolyPid's marketing application for D-PLEX100

PolyPid Ltd. announced on October 1, 2026 that the European Medicines Agency validated the company's Marketing Authorization Application for D-PLEX100, its lead candidate for preventing infections after abdominal surgery. The MAA was submitted to the EMA on September 14, 2026 under the Centralized Procedure on the basis of therapeutic innovation.¹ Validation confirms that the application is complete and marks the initiation of a formal regulatory review process.¹ The application will now enter formal review by the EMA's Committee for Medicinal Products for Human Use.¹

The submission follows meetings the company held with the EMA Rapporteur and Co-Rapporteur during the second quarter of 2026 regarding the planned application.¹ If approved, D-PLEX100 would receive a single marketing authorization valid throughout the European Union member states.¹

The application draws on PolyPid's clinical program for D-PLEX100. It is supported by the positive pivotal Phase 3 SHIELD II trial, which met its primary endpoint and all key secondary endpoints and showed a 60% relative risk reduction in surgical site infections compared with standard of care (p=0.0013).¹

In the United States, the FDA has accepted PolyPid's NDA for D-PLEX100 and granted Priority Review, with a PDUFA goal date of November 28, 2026.¹ PolyPid retains commercial rights to D-PLEX100 outside the U.S. and Canada, where the company has partnered with Azurity Pharmaceuticals.¹

D-PLEX100 previously received Breakthrough Therapy Designation from the FDA for the prevention of surgical site infections in patients undergoing elective colorectal surgery.¹ The product's delivery technology, Kynatrix, is designed to pair with active pharmaceutical ingredients to allow prolonged release of the antibiotic doxycycline at the surgical site for a period of 30 days.¹