PolyPid Initiates D-PLEX₁₀₀ NDA Submission to the FDA

Core Viewpoint - PolyPid Ltd. has initiated a New Drug Application (NDA) submission for D-PLEX₁₀₀ to the FDA for preventing surgical site infections in colorectal surgery, with completion expected in the second quarter of 2026 [2][4]. Group 1: NDA Submission Details - The NDA is submitted under the FDA's Fast Track designation, allowing for a rolling review process [3]. - The initial submission includes the Chemistry, Manufacturing and Controls (CMC) and nonclinical sections, with the clinical section to follow in the second quarter of 2026 [3]. Group 2: Product Information - D-PLEX₁₀₀ is designed to provide prolonged and controlled antibacterial activity at the surgical site, utilizing PolyPid's Kynatrix delivery technology to release doxycycline over 30 days [5]. - The product demonstrated a statistically significant 60% relative risk reduction in surgical site infection incidence in the Phase 3 SHIELD II trial [5]. Group 3: Company Overview - PolyPid Ltd. focuses on developing long-acting, controlled-release drugs to address unmet medical needs across various therapeutic areas, including surgical care and metabolic diseases [6]. - The company aims to redefine therapy performance and enhance patient care standards through innovation [6].