PolyPid says FDA accepts D-PLEX100 NDA, grants priority review - PYPD News | RalliesPolyPid says FDA accepts D-PLEX100 NDA, grants priority review
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PYPD• FDA accepts NDA and sets priority review timeline
- 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.
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