PolyPid Ltd. (Nasdaq: PYPD) has begun the New Drug Application (NDA) process with the U.S. Food and Drug Administration for its surgical site infection prevention product, D‑PLEX100. The company filed the Chemistry, Manufacturing and Controls (CMC) and non‑clinical sections of the NDA on March 31, 2026, and will submit clinical data in the second quarter of 2026. The filing is under the FDA’s Fast Track designation, which allows a rolling review schedule.
D‑PLEX100 delivers doxycycline via PolyPid’s proprietary Kynatrix™ technology, providing a 30‑day localized release at the surgical site. The NDA is backed by the Phase 3 SHIELD II trial, which reported a 58% to 60% relative risk reduction in surgical site infections. The product also received Breakthrough Therapy designation for prevention of SSIs in elective colorectal surgery, and a Qualified Infectious Disease Product designation, positioning it for market exclusivity upon approval.
PolyPid also secured a PDUFA fee waiver of approximately $4.3 million, easing the financial burden of the regulatory process. The company is in advanced discussions with a U.S. commercialization partner, a step that could accelerate market entry once approval is obtained. The combined regulatory and partnership progress underscores the company’s strategy to address the $3.3 billion to $10 billion annual cost burden of SSIs in the U.S.
“This submission marks a pivotal milestone for PolyPid as we advance D‑PLEX100 into its regulatory approval phase,” said Dikla Czaczkes Akselbrad, Chief Executive Officer of PolyPid. “Following the positive results from our successful Phase 3 SHIELD II trial and constructive feedback from our previously announced pre‑NDA meeting with the FDA, we are pleased to initiate the NDA submission.”
The FDA’s Fast Track and Breakthrough Therapy designations, coupled with the substantial fee waiver and ongoing partnership talks, position D‑PLEX100 to potentially capture a sizable share of the U.S. surgical site infection prevention market. The regulatory milestone signals that PolyPid is moving from clinical development toward commercial readiness, while the fee waiver and partnership discussions mitigate financial risk and support a scalable launch strategy.
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