Jazz Pharma comes up empty in late-stage defibrotide study

Jazz Pharmaceuticals (NASDAQ:JAZZ) slips 3% premarket on light volume on the heels of disappointing results from a Phase 3 clinical trial evaluating defibrotide for the prevention of hepatic veno-occlusive disease (VOD) after hematopoietic stem-cell transplantation (HSCT) in high-risk or very high-risk patients.

Enrollment was stopped early after the independent Data Monitoring Committee concluded that the study was unlikely to meet the primary endpoint based on an interim analysis of data on the first 280 participants.

The company says it will stop development for the indication but will stay the course in other studies.

The FDA approved defibrotide, branded as Defitelio, in March 2016 for the treatment of hepatic VOD after HSCT.

https://seekingalpha.com/news/3566968-jazz-pharma-comes-up-empty-in-late-stage-defibrotide-study