PolyPid Files D-PLEX₁₀₀ NDA under Fast Track, Cites 60% SSI Reduction
PolyPid submitted CMC and nonclinical modules of its New Drug Application for D-PLEX₁₀₀ under FDA Fast Track, targeting completion of rolling review in Q2 2026. Phase 3 SHIELD II trial demonstrated a 60% relative risk reduction in surgical site infections after colorectal surgery, and U.S. commercialization partnership talks are progressing.
1. New Drug Application Submission
PolyPid initiated submission of the Chemistry, Manufacturing and Controls and nonclinical modules for its New Drug Application for D-PLEX₁₀₀ to the FDA, marking the start of the rolling review process.
2. Fast Track Designation and Rolling Review
Under FDA Fast Track designation, PolyPid can submit NDA components sequentially, with the company planning to deliver the clinical section and finalize the submission in Q2 2026 to accelerate regulatory assessment.
3. Phase 3 SHIELD II Trial Results
Results from the Phase 3 SHIELD II trial showed a statistically significant 60% relative risk reduction (p=0.0013) in surgical site infections among patients undergoing colorectal surgery, achieving all primary and key secondary endpoints.
4. U.S. Commercialization Partnership Negotiations
PolyPid is advancing U.S. commercialization partnership discussions to secure market access and distribution for D-PLEX₁₀₀ following potential FDA approval, targeting rapid adoption in surgical care settings.