PolyPid Ltd. (PYPD) Form 6-K — Jun 1, 2026
PolyPid Ltd. (PYPD) announced the successful completion of its New Drug Application (NDA) submission to the FDA for D-PLEX100, its lead product candidate for preventing surgical site infections in colorectal surgery patients. The application is supported by positive results from the pivotal Phase 3 SHIELD II trial, which met its primary endpoint and demonstrated a 60% relative risk reduction in infections compared to standard of care (p=0.0013). The company anticipates a PDUFA target action date in the first quarter of 2027 and is currently finalizing U.S.
Key figures
- P value
- 0.0013
- Drug release duration
- 30 days
- Relative risk reduction
- 60%
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