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EMA validates PolyPid's Marketing Authorization Application for D-PLEX100, initiating formal review under the Centralized Procedure
PYPDPolyPid Ltd.
The European Medicines Agency validated PolyPid’s Marketing Authorization Application for D-PLEX₁₀₀, initiating formal review under the Centralized Procedure. This follows the U.S. FDA's acceptance of a New Drug Application with Priority Review and a PDUFA goal date of November 28, 2026. The application is supported by positive Phase 3 SHIELD II trial results showing a 60% relative risk reduction in surgical site infections. PolyPid Ltd. operates as an innovative biopharmaceutical company developing long-acting, controlled-release drugs for surgical care and metabolic diseases.