PolyPid Ltd., a late-stage biopharma company based in Israel, announced that it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2026 for its product D-PLEX100, following positive topline results from its Phase 3 SHIELD II trial. The trial demonstrated a significant reduction in surgical site infections in patients undergoing abdominal colorectal surgery. The product has received Fast Track designation from the FDA, indicating an expedited review process. A Marketing Authorization Application $(MAA)$ for the European Union is expected to follow shortly after the NDA submission.
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