PolyPid Ltd. is an advanced-stage biopharmaceutical company specializing in the development, manufacturing, and commercialization of therapeutic solutions. These solutions are based on its proprietary polymer-lipid encapsulation matrix (PLEX) platform, with the goal of addressing significant unmet medical needs. The company's leading product candidate, D-PLEX100, is currently undergoing Phase III clinical trials. It is being evaluated for its efficacy in preventing surgical site infections (SSIs) following both sternal (bone) and abdominal (soft tissue) procedures. Established in 2008, PolyPid Ltd. is headquartered in Petah Tikva, Israel.
PolyPid Provides Corporate Update and Reports Second Quarter 2026 Financial Results
PolyPid announced that the FDA accepted the NDA for D-PLEX₁₀₀ with Priority Review, setting a PDUFA goal date of November 28, 2026, which is approximately one quarter ahead of previous guidance.
Following the acceptance, the company achieved milestones triggering $30 million in upfront payments from partner Azurity Pharmaceuticals, which will handle exclusive U.S. and Canada commercialization with potential tiered royalties up to the mid-twenties.
PolyPid reported a Q2 net loss of $7.8 million, or $0.35 per share, and noted that the recent milestone payments extend its financial runway into 2028.