Leadership Transition
Renee Gala was appointed as the new CEO, effective August 11, 2025, succeeding Bruce Cozadd. This transition is expected to build on Jazz Pharmaceuticals' momentum and drive long-term growth.
FDA PDUFA Action Dates
Jazz Pharmaceuticals is anticipating key FDA PDUFA action dates for dordaviprone on August 18, 2025, and for Zepzelca on October 7, 2025, which could potentially expand treatment options for patients.
Revenue Growth
The second quarter of 2025 saw total revenue surpass $1 billion, with Xywav showing a 13% year-over-year increase and Epidiolex maintaining strong underlying demand.
Oncology Pipeline Developments
Positive progress in the oncology pipeline includes the potential approval of dordaviprone for H3 K27M-mutant diffuse glioma and Zepzelca in first-line maintenance for extensive-stage small cell lung cancer.
Ziihera Approval
Ziihera received conditional marketing authorization from the European Commission for second-line HER2-positive biliary tract cancer, enhancing Jazz's oncology portfolio.