Polypid surges on regulatory pathway for infection treatment

Polypid

24/01/2023 13:28

** Shares of Polypid Ltd  PYPD.O  surge 69.4% to $1.7
premarket
    ** Co reports positive update on regulatory pathway for its
abdominal surgery site infection treatment, D-PLEX100, based on
a recent communication with the U.S. FDA 
    ** Polypid says the regulator recommended that the company
conduct an additional study to support a potential marketing
application submission
    ** However, the regulator stated that an ongoing late-stage
study, which has enrolled over 200 patients so far, could
potentially serve as such a study
    ** Co says it is now working to finalize the design of a
revised trial; expects to resume patient recruitment next
quarter 
    ** Co says the FDA acknowledged that data from PYPD's
previous late-stage trial may provide supportive evidence on a
specified subgroup 
    ** D-PLEX100, in early September 2022, did not achieve a key
goal in late-stage study 
    ** Israel-based biopharm's stock lost 87.9% in 2022
 (Reporting by Pratik Jain in Bengaluru)
 ((Pratik.Jain@thomsonreuters.com;))