PolyPid Announces FDA Waiver for D-PLEX100
PolyPid Ltd., a biopharmaceutical company, announced on March 17, 2026, that the U.S. Food and Drug Administration (FDA) granted a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee, amounting to approximately $4.3 million, for the New Drug Application (NDA) of its lead product candidate D-PLEX100, which targets the prevention of surgical site infections in abdominal colorectal surgeries, according to GlobeNewswire PE.
Details of the Waiver and Company Progress
This waiver enables PolyPid to focus resources on commercialization preparations, as the company remains on track to initiate the first sections of its rolling NDA submission by the end of March 2026, following positive feedback from the FDA during a pre-NDA meeting communication in December 2025. The Phase 3 SHIELD II trial for D-PLEX100 demonstrated a 60% relative risk reduction in surgical site infections, with a p-value of 0.0013, meeting its primary and all key secondary endpoints, as detailed in the announcement from PolyPid.
Background on D-PLEX100
D-PLEX100 is designed to provide local, prolonged anti-bacterial activity at the surgical site using PolyPid’s Kynatrix delivery technology, which pairs with the antibiotic doxycycline to enable a continuous release for 30 days, aiming to prevent infections including those from antibiotic-resistant bacteria. The product candidate recently showed positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions, according to GlobeNewswire PE.
PolyPid’s Next Steps
PolyPid is in advanced stages of commercial partnership discussions for the U.S. market, as stated in the announcement, while preparing for the NDA submission. The company’s CEO, Dikla Czaczkes Akselbrad, noted that the waiver comes days before the planned NDA submission, following the successful SHIELD II trial results and FDA engagement, with the company expecting progress in addressing unmet needs in surgical infection prevention.
