D-PLEX100 - (SHIELD II)

August 12, 2026: PolyPid Ltd. (NASDAQ: PYPD) said the FDA accepted the NDA for D-PLEX100 with Priority Review for prevention of surgical site infections in patients undergoing abdominal colorectal surgery, setting a PDUFA goal date of November 28, 2026; the company said FDA identified no filing review issues. The NDA is supported by the Phase 3 SHIELD II trial, which met the primary endpoint and all key secondary endpoints and showed a 60% relative risk reduction in SSIs versus standard of care (p=0.0013).

For commercialization, PolyPid said it entered an exclusive U.S. and Canada partnership with Azurity Pharmaceuticals on July 17, 2026. Following NDA acceptance, PolyPid said it achieved $30 million in upfront and near-term milestone payments, with eligibility for about $320 million total upfront/milestones and tiered royalties from mid-teens to mid-twenties on U.S./Canada sales. Azurity will also fund clinical development for potential label expansion beyond abdominal surgery in those markets.

Upcoming catalysts: EMA MAA submission for D-PLEX100 remains on track for Q3 2026, and a potential U.S. commercial launch is targeted for early 2027. PolyPid also said it is advancing additional Kynatrix-based metabolic and infection programs, but no specific data were disclosed.