European Medicines Agency Validates PolyPid’s Marketing Authorization Application for D-PLEX₁₀₀
Globe Newswire•01/10/2026•09:15 ET
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Key Highlights
- ➤EMA validates PolyPid (PYPD) MAA for D-PLEX₁₀₀, initiating formal review
- ➤FDA Priority Review continues for D-PLEX₁₀₀ NDA, with November 28, 2026 PDUFA goal date
- ➤SHIELD II showed 60% relative risk reduction in SSIs versus standard of care (p=0.0013)
- ➤EU centralized approval, if granted, would cover European Union member states
Expert Statements
Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid
“Validation of the MAA for D-PLEX₁₀₀ marks another important step toward potential commercialization in major global markets”
PolyPid Submitted Marketing Authorization Application to European Medicines Agency for D-PLEX₁₀₀ Last month
Validation confirms that the application is complete and EMA initiates formal review of D-PLEX₁₀₀
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