USFDAJun 1, 2026, 08:31 AM
PolyPid Completes NDA Submission for D-PLEX100; FDA Decision Q1 2027
AI Summary
PolyPid Ltd. announced the successful completion of its New Drug Application (NDA) submission to the U.S. FDA for D-PLEX100, its lead product candidate for preventing surgical site infections (SSIs) in colorectal surgery patients. The NDA is supported by positive Phase 3 SHIELD II trial results, which demonstrated a 60% relative risk reduction in SSIs. The company anticipates a potential FDA decision in the first quarter of 2027 under the PDUFA review timeline, with D-PLEX100 having received Breakthrough Therapy, Fast Track, and QIDP designations.
Key Highlights
- PolyPid successfully completed NDA submission for D-PLEX100 to FDA.
- D-PLEX100 is for prevention of surgical site infections (SSIs) in colorectal surgery.
- PDUFA target action date is planned for Q1 2027.
- NDA supported by pivotal Phase 3 SHIELD II trial results.
- SHIELD II trial showed 60% relative risk reduction in SSIs (p=0.0013).
- D-PLEX100 received FDA Breakthrough Therapy, Fast Track, and QIDP designations.
- Company is finalizing U.S. commercial partnership discussions.
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