Jazz Pharmaceuticals reports 2Q26 results, raises 2026 revenue guidance
Jazz reported record quarterly revenue of $1.2 billion and set up a possible near-term launch of Ziihera in a new gastric cancer indication.
Jazz Pharmaceuticals said the FDA granted Priority Review and set a PDUFA target action date of August 25, 2026 for a supplemental Biologics License Application for zanidatamab containing combinations in first-line gastroesophageal adenocarcinoma.1 The company said it is prepared to launch zanidatamab in HER2+ first-line GEA around that PDUFA date.1
Data from the Phase 3 "HERIZON-GEA-01" trial were published in The New England Journal of Medicine, with additional subgroup analyses presented at the 2026 ASCO Annual Meeting showing benefit with zanidatamab-containing combinations across PD-L1 expression levels, including in patients who were PD-L1-negative.1 Separately, the FDA granted Breakthrough Therapy designation to zanidatamab in adults with previously treated, locally advanced, unresectable, or metastatic HER2-positive colorectal cancer.1 The company said top-line results from the second interim overall survival analysis for the HERIZON-GEA-01 trial doublet regimen are expected in the third quarter of 2026.1
On Zepzelca, the company said that based on results from the LAGOON trial in second-line metastatic small cell lung cancer, it will submit, in alignment with the FDA, a labeling supplement in the third quarter of 2026 to remove the second-line indication, while the first-line maintenance indication will not be affected.1
For Modeyso, the company said it anticipates the overall survival interim analysis for the event-driven Phase 3 ACTION trial in the first half of 2027, based on the current pace of event accrual.1
On finances, Jazz raised its 2026 revenue guidance range to $4.60 to $4.75 billion, citing anticipated double-digit year-over-year growth from Xywav and its combined epilepsy and oncology franchises.1 As of June 30, 2026, cash, cash equivalents and investments were $2.2 billion, and outstanding long-term debt principal was $4.4 billion,1 with undrawn revolving credit capacity of $885 million.1 The company also said it repaid $1.0 billion in aggregate principal of its 2.00% exchangeable senior notes due 2026 in June 2026.1
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