“PolyPid (PYPD) is on track for a transformational year in 2025. We continue to view the SHIELD II Phase 3 trial as a derisked study. This assessment has been further strengthened by the 800-patient sample size reassessment which helps ensure the study has sufficient power to conclusively confirm D-PLEX100’s treatment benefit and we believe this increases the trial’s overall probability of success,” stated Dikla Czaczkes Akselbrad, PolyPid’s Chief Executive Officer. “As we await the top-line results from SHIELD II later this quarter, we continue to advance our preparations for NDA and MAA submissions in 2026. Moreover, we continue to progress our commercial plans, as well as engage in partnership discussions with multiple potential partners in the United States.”
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