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European Medicines Agency Validates PolyPid’s Marketing Authorization Application for D-PLEX₁₀₀

PolyPid (PYPD)PolyPidFDA / regulatory

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 D-PLEX₁₀₀ NDA concurrently under FDA Priority Review with November 28, 2026 PDUFA goal date

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PolyPid

Local Controlled-Release Therapeutics PolyPid develops long-acting medicines that release active drugs directly at a surgical or disease site. This approach is intended to improve local exposure while limiting systemic treatment burden. PLEX Technology The PLEX platform embeds drugs within a biodegradable polymer-lipid matrix to control...

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