PolyPid’s stock surged after the FDA accepted its New Drug Application for D-PLEX100 under priority review status.
PolyPid (PYPD) shares climbed over 7% following the FDA’s decision to grant priority review to its lead product candidate, D-PLEX100. The company’s New Drug Application (NDA) seeks U.S. approval for the drug, which targets surgical site infections.
The priority review designation shortens the FDA’s evaluation timeline to six months from the standard ten. PolyPid previously reported positive Phase 3 trial results for D-PLEX100, positioning it as a potential first-in-class therapy.
The stock’s gain reflects investor optimism about accelerated regulatory progress and commercialization prospects.