dordaviprone — Interim data
1H27
• Anticipate the OS interim analysis for the event-driven Phase 3 ACTION trial in 1H27, based on current pace of event accrual.Source filing
JAZZ biotech catalysts & pipeline
JAZZ PHARMACEUTICALS PLC · Data as of 2026-09-08
Upcoming catalysts
lurbinectedin — Supplemental NDA/BLA submission
Q3 2026
In addition, our partner PharmaMar, conducted the Phase 3 LAGOON confirmatory trial evaluating Zepzelca in patients with second-line metastatic SCLC. In June 2026, we announced top-line results from the LAGOON trial, which did not meet its primary OS endpoint evaluating Zepzelca as monotherapy or in combination with irinotecan compared with investigators' choice of topotecan or irinotecan. No new safety signals were identified with Zepzelca monotherapy or in combination with irinotecan. Based on the results from the LAGOON trial of Zepzelca in second-line metastatic SCLC, which were reported in June 2026, and in alignment with FDA, in the third quarter of 2026, we will submit for FDA's review and subsequent action a labeling supplement to remove the second-line indication. The first-line maintenance indication will not be affected.Source filing
zanidatamab — Topline data
Sep 2027–Apr 2028
• EmpowHER-BC-303 trial in mBC patients previously treated with, or intolerant to, trastuzumab deruxtecan on track to complete enrollment in 1H27, with top-line results expected in late 2027 or early 2028.Source filing
zanidatamab — Conference presentation
Q4 2026
Data submitted for presentation in fourth quarter 2026Source filing