PolyPid Announces Positive FDA Pre-NDA Meeting Minutes for D-PLEX₁₀₀ Supporting NDA Submission

Core Viewpoint - PolyPid Ltd. is set to submit a New Drug Application (NDA) for its lead product candidate D-PLEX100, aimed at preventing surgical site infections in abdominal colorectal surgeries, with submissions beginning in early 2026 following positive feedback from the FDA [1][2][4]. Group 1: NDA Submission and FDA Interaction - The FDA has confirmed that PolyPid's existing clinical data, including results from the Phase 3 SHIELD II trial, is adequate for NDA submission and review [2][4]. - A rolling NDA review has been agreed upon, allowing PolyPid to submit completed sections starting in early 2026 [2][4]. - The in-person pre-NDA meeting originally scheduled for December 3, 2025, is no longer necessary as the objectives have been met [3]. Group 2: Product Details and Clinical Results - D-PLEX100 utilizes PLEX technology to provide prolonged and controlled antibacterial activity at the surgical site, releasing doxycycline over 30 days to prevent surgical site infections [5][6]. - The Phase 3 SHIELD II trial demonstrated a statistically significant 58% relative risk reduction in surgical site infection incidence following abdominal colorectal surgery with large incisions [5]. - D-PLEX100 has received Breakthrough Therapy designation from the FDA for its potential in preventing surgical site infections in elective colorectal surgery patients [5]. Group 3: Company Overview - PolyPid Ltd. is a late-stage biopharma company focused on improving surgical outcomes through locally administered therapeutics [6]. - The company is also developing an innovative pipeline targeting oncology, obesity, and diabetes [6].