PolyPid Receives FDA Small Business Waiver For $4.3M PDUFA Fee As It Prepares NDA Submission For D-PLEX100

PolyPid Ltd., a biopharmaceutical company focused on improving patient outcomes by enhancing treatment effectiveness at the point of care, announced that the U.S. Food and Drug Administration (FDA) has granted the company a small business waiver for the Prescription Drug User Fee Act (PDUFA) fee. The waived fee, which amounts to approximately $4.3 million, applies to the New Drug Application (NDA) for D-PLEX100, PolyPid’s lead therapeutic candidate designed to prevent surgical site infections in abdominal colorectal surgeries.

This waiver represents an important milestone for PolyPid as it prepares to begin submitting its NDA. By eliminating the substantial financial obligation associated with the PDUFA fee, the company can direct more of its resources toward commercialization planning. 

This progress follows the strong results from the Phase 3 SHIELD II trial, which showed a 60% relative risk reduction in surgical site infections and successfully met its primary and all key secondary endpoints. PolyPid has confirmed that it remains on schedule to submit the first sections of its rolling NDA by the end of the month, supported by positive guidance from the FDA during the pre-NDA discussions completed in December 2025.

Commenting on the development, Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid, stated that receiving the waiver just ahead of the planned NDA submission is a significant achievement. She noted that the SHIELD II Phase 3 results, combined with constructive FDA interactions, have helped position the company for meaningful progress in bringing D-PLEX100 to patients. 

With the product targeting a major unmet need in the prevention of surgical infections, PolyPid is currently in advanced discussions regarding commercial partnerships in the United States. The company expects the coming year to be pivotal as it prepares for the potential introduction of D-PLEX100 to the market.