USFDAJul 29, 2026, 08:31 AM
PolyPid D-PLEX100 NDA Accepted by FDA with Priority Review
AI Summary
PolyPid Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for D-PLEX100. The FDA granted Priority Review and set a PDUFA target action date of November 28, 2026, which is approximately one quarter ahead of the company's previously communicated guidance. The FDA identified no filing review issues, and this acceptance triggers a $15 million milestone payment from Azurity Pharmaceuticals, completing $30 million in upfront and near-term milestone payments under their commercialization partnership.
Key Highlights
- FDA accepted NDA for D-PLEX100 with Priority Review.
- PDUFA target action date set for November 28, 2026.
- Date is approximately one quarter ahead of previous guidance.
- FDA identified no filing review issues for the NDA.
- Acceptance triggered a $15 million milestone payment from Azurity Pharmaceuticals.
- Completes $30 million in upfront and near-term milestone payments.
- D-PLEX100 is for prevention of surgical site infections in abdominal colorectal surgery.
Price Impact
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