PolyPid-Azurity D-PLEX100 partnership

PolyPid Ltd. (Nasdaq: PYPD) and KC Pharmaceuticals announced an exclusive commercial partnership for D-PLEX100 in the United States and Canada for the prevention of abdominal colorectal surgical site infections (SSIs). Under the agreement, PolyPid will receive $15 million upfront and an additional $15 million upon FDA acceptance of the New Drug Application (NDA), expected in August 2026. PolyPid is eligible for up to approximately $300 million in additional regulatory, development, and sales-based milestone payments, plus tiered royalties from mid-teen to mid-twenties percentages on net sales. Azurity will commercialize D-PLEX100 upon approval, while PolyPid retains manufacturing rights and global rights outside the U.S. and Canada. The partnership follows positive Phase 3 SHIELD II trial results, where D-PLEX100 met its primary endpoint and showed a 60% relative risk reduction in SSI incidence. Azurity will also fund potential label expansion into additional SSI indications. The U.S. launch is targeted for the first quarter of 2027.