India, Nov. 11 -- PolyPid (PYPD) reported third-quarter 2026 results while outlining progress for D-PLEX100, its lead candidate for the prevention of surgical site infections, while introducing a new product candidate under its long-term growth strategy.
D-PLEX100 is currently under FDA Priority Review with a PDUFA decision date of November 28, 2026. The company and its U.S. commercialization partner, Azurity Pharmaceuticals, are preparing for a potential U.S. launch in early 2027, subject to FDA approval.
PolyPid also reported that its European marketing application for D-PLEX100 has been submitted and validated by the European Medicines Agency (EMA), with a regulatory decision expected in the second half of 2027. The company has also re...