PolyPid receives pre-NDA meeting minutes for D-Plex supporting NDA submission

PolyPid (PYPD) announced that it has received a formal pre-New Drug Application, NDA, meeting minutes from the U.S. Food and Drug Administration, FDA, supporting the NDA submission of D-PLEX100, the Company’s lead product candidate for the prevention of surgical site infections in abdominal colorectal surgeries. The FDA agreed that the Company’s existing clinical data package, including results from the Phase 3 SHIELD II trial, appears adequate to support NDA submission and review. The FDA also agreed to a rolling NDA review, allowing PolyPid to submit the first completed sections in early 2026. Based on the FDA’s Pre-NDA meeting written response, the Company concludes that the objectives of the pre-NDA meeting have been accomplished and has determined that the in-person meeting, originally scheduled for December 3, 2025, is no longer necessary.