PolyPid reports Q2 2026 results, FDA priority review for D-PLEX100

PolyPid Ltd. reported second quarter 2026 financial results and a corporate update on August 12, 2026. The company said on July 27, 2026, the FDA accepted the D-PLEX₁₀₀ NDA submission and granted Priority Review, with a PDUFA goal date of November 28, 2026, approximately one quarter ahead of the company's previously communicated first quarter 2027 guidance.¹ The company added that the FDA did not identify any filing review issues in its acceptance communications.¹

The NDA was supported by positive results from the pivotal Phase 3 SHIELD II trial, which met its primary endpoint and all key secondary endpoints and demonstrated a 60% relative risk reduction in SSIs compared to standard of care (p=0.0013).¹

On July 17, 2026, PolyPid entered a commercialization agreement with Azurity Pharmaceuticals, described as a privately held global specialty pharmaceutical company with a first-in-class commercial model, deep experience in specialty and hospital-based therapies with more than 50 medicines across 10 therapeutic areas.¹ Following the NDA acceptance, PolyPid achieved the milestones required for the $30 million in upfront and near-term milestone payments from Azurity.¹ Under the deal, PolyPid is eligible to receive up to approximately $320 million in total upfront and milestone payments, inclusive of the $30 million confirmed to date.¹ The company is also entitled to tiered royalties from mid-teen to mid-twenties percentages on sales in the U.S. and Canada.¹ A potential U.S. launch is targeted for early 2027.¹

Financially, PolyPid reported a net loss of $7.8 million, or $(0.35) per share, for the three months ended June 30, 2026, compared to a net loss of $10.0 million, or $(0.78) per share, a year earlier.¹ As of June 30, 2026, the company had cash and cash equivalents of $6.6 million, not including $30 million in upfront and near-term milestone payments from Azurity.¹ PolyPid said it believes its current cash position, together with expected proceeds from the commercialization agreement and other potential proceeds, will be sufficient to fund operations into 2028.¹