EL7.AI
StocksMedium•29 July 2026•
1 min read

FDA Grants Priority Review to PolyPid’s D-PLEX₁₀₀ NDA

Key Facts

1PolyPid announced FDA acceptance of the NDA for D-PLEX₁₀₀ with Priority Review granted.
2The PDUFA target action date is set for November 28, 2026.
3The target date is approximately one quarter ahead of the company's previous guidance.

In a move reflecting the accelerating pace of biotech innovation in surgical infection prevention, PolyPid announced that the U.S. FDA has accepted its New Drug Application (NDA) for D-PLEX₁₀₀. The agency granted the filing Priority Review status, bolstering hopes for an earlier-than-expected market entry for the treatment. According to reports, the FDA did not identify any filing review issues during the initial acceptance process.

This development marks a significant shift in the company's regulatory timeline, with the PDUFA target action date now set for November 28, 2026. This date is approximately one quarter ahead of the company's previous guidance which pointed toward Q1 2027. The acceleration follows positive clinical data from the Phase 3 SHIELD II trial, which demonstrated a 60% relative risk reduction in surgical site infections for colorectal surgery patients.

Financially, the NDA acceptance triggers a $15 million milestone payment from commercial partner Azurity Pharmaceuticals, completing a total of $30 million in upfront and near-term payments.