PolyPid completes Israeli Ministry of Health GMP inspection

PolyPid (PYPD) announced the successful completion of a routine Good Manufacturing Practice, GMP, inspection by the Israeli Ministry of Health. The inspection, concluded earlier this week, marks the fourth consecutive successful GMP inspection of PolyPid’s manufacturing facility. “Successfully completing this inspection demonstrates our consistent adherence to international GMP standards and validates our quality systems for commercial-scale manufacturing,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “As we advance toward our planned New Drug Application submission for D-PLEX in early 2026, this inspection serves as crucial real-world preparation for the U.S. Food and Drug Administration facility inspection that will follow. With positive Phase 3 SHIELD II results in hand, confirming our manufacturing readiness represents another step toward bringing D-PLEX to patients.”