D-PLEX100 - (SHIELD II)

July 29, 2026: PolyPid Ltd. (NASDAQ: PYPD) said the FDA accepted for filing its New Drug Application (NDA) for D-PLEX100 to prevent surgical site infections (SSIs) in patients undergoing abdominal colorectal surgery, and granted Priority Review. The FDA identified no filing review issues and set a PDUFA target action date of November 28, 2026 (about one quarter earlier than the company’s prior Q1 2027 guidance); Priority Review shortens the target review timeline to ~6 months from 10 months.

The NDA acceptance triggers a $15 million milestone payment from Azurity Pharmaceuticals, completing $30 million in upfront and near-term milestones under the exclusive U.S. and Canada commercialization partnership signed July 17, 2026. PolyPid plans to support the FDA review through the PDUFA date, with a potential U.S. launch by Azurity in early 2027 if approved.

The release notes D-PLEX100 (local controlled-release doxycycline via Kynatrix) showed positive Phase 3 SHIELD II results, meeting the primary endpoint and showing a 60% relative risk reduction at a secondary endpoint in SSI incidence (p=0.0013) after abdominal colorectal surgery with large incisions, and has FDA Breakthrough Therapy Designation for elective colorectal surgery SSI prevention.