Microvast Holdings announces departure of chief financial officer
Investing.com -- Shares of PolyPid Ltd. (NASDAQ:PYPD) soared 10.1% following the announcement of positive Phase 3 trial results for its D-PLEX100 product, aimed at preventing surgical site infections (SSIs) in abdominal surgeries. The company’s pivotal SHIELD II trial met its primary efficacy endpoint, showing statistically significant results in a study of 798 patients.
PolyPid revealed that the D-PLEX100, combined with standard of care, significantly reduced SSIs by 58% compared to standard of care alone. This achievement has set the stage for a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in early 2026, with plans for a subsequent Marketing Authorization Application (MAA) in the European Union.
The company’s CEO, Dikla Czaczkes Akselbrad, expressed confidence in D-PLEX100’s potential to lower hospital costs and its value as an addition to the standard of care. She also highlighted the product’s market potential, targeting over 12 million annual surgeries in the U.S. alone.
Further bolstering investor confidence, the SHIELD II study met all key secondary efficacy endpoints, including a 38% reduction in the combination of deep and superficial SSIs, mortality, and surgical reinterventions at the incision site. The trial’s success has prompted expectations that D-PLEX100 will become a vital component of the surgical care bundle for colorectal surgeries, as noted by Emeritus Professor of Surgery Charles E. Edmiston, Jr.
Investors reacted positively to the robust data, which PolyPid believes will accelerate global partnership discussions. The company also emphasized the absence of safety concerns raised by the independent Data Safety Monitoring Board during the trial, further underscoring the promising future of D-PLEX100 in surgical applications.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.