PolyPid announced that the U.S. Food and Drug Administration accepted its New Drug Application for D-PLEX 100 with Priority Review status, setting a PDUFA target action date of November 28, 2026. This acceptance triggers a $15 million milestone payment from commercial partner Azurity Pharmaceuticals, completing the $30 million in upfront and near-term payments under their July 17, 2026 partnership agreement. The Priority Review designation shortens the FDA review timeline to approximately six months, accelerating the potential U.S. launch by early 2027. PolyPid is an innovative biopharmaceutical company developing long-acting, controlled-release drugs for surgical care and metabolic diseases.
