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PolyPid Completes Rolling NDA Submission to FDA for D-PLEX100
PolyPid (PYPD) has completed its rolling new drug application submission to the US Food and Drug Administration for D-PLEX100 for the prevention of surgical site infections in patients undergoing colorectal surgery, the company said Monday.The company said it expects a potential FDA decision in Q1 2027 under the Prescription Drug User Fee Act review timeline.The submission is backed by data from a Phase 3 trial in which D-PLEX100 met its primary and all key secondary endpoints, and reduced surgical site infection risk by 60% compared with standard of care, PolyPid said.Price: $4.74, Change: $+0.02, Percent Change: +0.32%
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