Page updated ·next FDA decision on the calendar·Data as of Nov 5, 2026 5:03 AM ET
D-PLEX100 is a PolyPid Ltd. program in prevention of surgical site infections in patients undergoing abdominal colorectal surgery. Its PDUFA date is Nov 28, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Prevention of surgical site infections in patients undergoing abdominal colorectal surgery. Sponsor: PolyPid Ltd. (PYPD). Market-cap tier at the time we tracked it: Micro. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
D-PLEX100's PDUFA date is Nov 28, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at D-PLEX100's most recent FDA decision?
No FDA decision for D-PLEX100 is in our archive yet.
What is D-PLEX100 used for?
In our records D-PLEX100 is under review or in development for Prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
Who makes D-PLEX100?
PolyPid Ltd. (PYPD).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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