PolyPid Initiates FDA Rolling Submission for D-PLEX₁₀₀

Key Facts

1PolyPid initiated a New Drug Application (NDA) submission to the U.S. FDA for D-PLEX₁₀₀.

2The drug targets the prevention of surgical site infections (SSIs) in patients undergoing colorectal surgery.

3Completion of the submission is expected in the second quarter of 2026 as part of a rolling review.

PolyPid Ltd. (Nasdaq: PYPD) has officially commenced the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). The application is for D-PLEX₁₀₀, a specialized product designed to prevent surgical site infections (SSIs) in patients undergoing colorectal surgery. This regulatory step marks a significant milestone for the biopharmaceutical company as it moves toward potential commercialization in the United States. The FDA's rolling review process allows PolyPid to submit completed sections of the application for review as they become available. The company expects to complete the full submission process by the second quarter of 2026. While the initiation is a positive catalyst for the stock, the extended timeline reflects the rigorous regulatory path ahead for the drug's final approval.