Upcoming FDA decision · November 28, 2026
D-PLEX PDUFA date: FDA decision expected November 28, 2026
43 days to goPolyPid Ltd. (PYPD) (PYPD) →
The FDA is expected to decide on D-PLEX from PolyPid Ltd. (PYPD) in Prevention of surgical site infections in abdominal colorectal surgery by the PDUFA target action date of November 28, 2026. For Prevention of surgical site infections in abdominal colorectal surgery. NDA, Priority Review. Verified against the company announcement on 2026-10-16.
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 16, 2026. Confirm dates against the company's or the FDA's announcement before acting.
November 28
Target action date
Phase 3
Stage
Verified
Date confidence
—
FDA designations
Questions about this FDA decision
- When is the PDUFA date for D-PLEX?
- The FDA's PDUFA target action date for D-PLEX is November 28, 2026. The FDA can act before that date, and the review can be extended.
- What is D-PLEX being reviewed for?
- The application under FDA review covers Prevention of surgical site infections in abdominal colorectal surgery.
- Which company is developing D-PLEX?
- PolyPid Ltd. (PYPD) (PYPD).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).