PolyPid Ltd. received formal pre‑New Drug Application meeting minutes from the U.S. Food and Drug Administration confirming that its Phase 3 SHIELD II data package for D‑PLEX100 is adequate to support an NDA submission, marking a key regulatory milestone for the company.
The FDA also agreed to a rolling NDA review, allowing PolyPid to submit completed sections in early 2026. This accelerated timeline reduces regulatory uncertainty and positions the company to move more quickly toward commercialization.
The SHIELD II trial demonstrated a 58% relative risk reduction in surgical site infection incidence after abdominal colorectal surgery with large incisions, underscoring the clinical benefit of D‑PLEX100 and supporting the company’s Breakthrough Therapy designation.
PolyPid remains a clinical‑stage company with no revenue and negative earnings; its cash runway extends into 2026. The regulatory progress now positions the company to potentially generate revenue in the U.S. and European markets, where the surgical site infection prevention market is estimated at $6.7 billion.
CEO Dikla Czaczkes Akselbrad expressed confidence, noting that the FDA’s endorsement validates the company’s regulatory strategy and strengthens its competitive position in a market with no direct competitors offering a localized, sustained‑release antibiotic delivery system.
Analysts highlighted the FDA’s endorsement as a key driver of positive market sentiment, citing the de‑risking effect of the rolling review and the strong clinical data.
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