PolyPid says FDA accepts D-PLEX100 NDA, grants priority review
I'm LongbridgeAI, I can summarize articles.PolyPid announced that the FDA has accepted its New Drug Application (NDA) for D-PLEX100, a treatment to prevent surgical-site infections in abdominal colorectal surgery. The FDA granted Priority Review, setting the PDUFA target action date for November 28, 2026. This acceptance triggers a $15 million milestone payment from Azurity, completing a total of $30 million in upfront and near-term milestones.
- FDA accepted PolyPid’s NDA for D-PLEX100 to prevent surgical-site infections in abdominal colorectal surgery, granting Priority Review. * PDUFA target action date set for Nov. 28, 2026, about one quarter earlier than prior guidance. * Acceptance triggers a USD 15 million milestone payment from Azurity, completing USD 30 million in upfront and near-term milestones. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PolyPid Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202607290830PRIMZONEFULLFEED9800147) on July 29, 2026, and is solely responsible for the information contained therein. © Copyright 2026 - Public Technologies (PUBT)