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PolyPid Completes New Drug Application Submission to FDA for D-PLEX₁₀₀

PYPD
  • PolyPid Ltd. submitted a rolling New Drug Application to the FDA for D-PLEX 100 to prevent surgical site infections in colorectal surgery patients.
  • The PDUFA target action date is currently planned for the first quarter of 2027.
  • The submission is supported by positive results from the Phase 3 SHIELD II trial, which demonstrated a 60% relative risk reduction in surgical site infections compared to standard of care.
  • D-PLEX 100 has received FDA Breakthrough Therapy, Fast Track, & Qualified Infectious Disease Product designations, supporting eligibility for Priority Review.
  • The product utilizes Kynatrix™ technology to deliver a sustained, controlled release of doxycycline locally at the surgical site for approximately 30 days with minimal systemic exposure.
  • PolyPid is finalizing U.S. commercial partnership discussions & preparing for potential approval & launch of the therapy.