By Chris Wack


PolyPid Ltd. shares were up 28% at $1.24 each after the company said it had positive regulatory news for D-PLEX for the prevention of abdominal colorectal surgical site infections.

The company said that following a recent type D meeting communication with the U.S. Food and Drug Administration on Phase 3 data, it now has clarity regarding the regulatory pathway toward a potential New Drug Application submission.

PolyPid provided to the FDA currently available data from the study evaluating D-PLEX for the prevention of abdominal colorectal SSIs. Based on the data, the FDA acknowledged that the trial results may provide supportive evidence on this population and recommended that the company conduct an additional study to support a potential NDA submission.

The FDA stated that the ongoing study, which to date has enrolled more than 200 patients, could potentially serve as such a study. PolyPid is now working to finalize the design of the revised trial, and expects to resume patient recruitment next quarter.

PolyPid shares are down 76% in the past 12 months.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

01-24-23 1009ET