PolyPid Ltd. reported second quarter 2026 financial results and announced that the FDA accepted its New Drug Application for D-PLEX₁₀₀ with Priority Review, setting a PDUFA goal date of November 28, 2026. The company entered an exclusive U.S. and Canada commercialization partnership with Azurity Pharmaceuticals, achieving $30 million in upfront and near-term milestone payments following NDA acceptance, with potential total milestones up to approximately $320 million plus tiered royalties. For the three months ended June 30, 2026, PolyPid reported a net loss of $7.8 million ($0.35 per share) compared to $10.0 million in the prior year period. As of June 30, 2026, cash and cash equivalents were $6.6 million. The company operates as an innovative biopharmaceutical firm developing long-acting, controlled-release drugs for surgical care and metabolic diseases.
