PolyPid submits D-PLEX100 NDA to FDA under rolling review
PUBT · 06/01 12:32
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- PolyPid completed a rolling NDA submission to the FDA for D-PLEX100 to prevent surgical site infections in colorectal surgery.
- FDA action date is targeted for Q1 2027 under the PDUFA timeline.
- Application is backed by Phase 3 SHIELD II data showing a 60% relative risk reduction in infections versus standard care (p=0.0013).
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: 202606010830PRIMZONEFULLFEED9727248) on June 01, 2026, and is solely responsible for the information contained therein.
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