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JAZZ 資訊
JAZZ 事件
Jazz Pharmaceuticals Updates Ziihera Survival Results
Jazz Pharmaceuticals announced updated overall survival results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera in combination with chemotherapy, with or without Tevimbra, as first-line treatment for adults with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. The results from the second interim, and final formal, analysis were presented as a late-breaking rapid oral presentation at the European Society for Medical Oncology Congress 2026 in Madrid, Spain. At the data cutoff, median follow-up was 35.3 months, 9.4 months longer than at the first interim analysis. "These HERIZON-GEA-01 three-year landmark results demonstrate meaningful survival outcomes for patients with HER2+ advanced GEA. The statistically significant survival benefit observed with Ziihera plus chemotherapy and the durable outcomes seen with Ziihera plus tislelizumab and chemotherapy cement Ziihera as the new HER2-targeted backbone therapy in first-line HER2+ advanced GEA," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of R&D, and chief medical officer of Jazz Pharmaceuticals.
Jazz Pharmaceuticals Completes $820M Acquisition of Actio Biosciences
Jazz Pharmaceuticals announced the successful completion of its acquisition of privately-held Actio Biosciences for $820M upfront. Actio is now a wholly-owned subsidiary of Jazz.
Jazz Pharmaceuticals Reports Positive Results for Ziihera in Clinical Trial
Jazz Pharmaceuticals announced second interim top-line overall survival results from the Phase 3 HERIZON-GEA-01 trial showing that Ziihera in combination with chemotherapy demonstrated statistically significant and clinically meaningful improvements in OS compared with trastuzumab plus chemotherapy as first-line treatment for adults with HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. The Ziihera plus chemotherapy OS hazard ratio improved compared with the first interim analysis. The safety profile of Ziihera in combination with chemotherapy was generally consistent with the known safety profile of each agent and the previously reported data from HERIZON-GEA-01, with no new safety signals observed. With longer follow up, the Ziihera plus Tevimbra and chemotherapy OS hazard ratio improved compared with the first interim analysis. These results build on the previous positive data, published in The New England Journal of Medicine, further demonstrating statistically significant, clinically meaningful and durable OS improvement for Ziihera plus tislelizumab and chemotherapy. On August 25, the FDA approved Ziihera in combination with tislelizumab and chemotherapy, for the first-line treatment of adults with HER2+ unresectable locally advanced or metastatic GEA, and Ziihera in combination with chemotherapy in the same setting for patients with HER2+ disease. Jazz has submitted these data for presentation at a major medical meeting in the fourth quarter 2026 and will also submit these data to global health authorities.
Jazz Pharmaceuticals Prices $1.1 Billion Exchangeable Senior Notes
Jazz Pharmaceuticals announced the pricing of $1.1 billion aggregate principal amount of 1.875% exchangeable senior notes due 2032 in a private offering by Jazz Investments I Limited, its wholly-owned subsidiary , to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. The offering was upsized from the previously announced offering size of $1.0 billion aggregate principal amount of notes. The initial exchange rate will be 2.8150 ordinary shares per $1,000 principal amount of notes (equivalent to an initial exchange price of approximately $355.24 per ordinary share, which represents a premium of approximately 42.5% above the last reported sale price per ordinary share on the Nasdaq Global Select Market on August 26, 2026.
Roche Receives FDA Approval for Expanded HER2 Testing
Roche (RHHBY) announced that it has received FDA approval for expanded use of its PATHWAY HER2 and VENTANA HER2 Dual ISH DNA Probe Cocktail tests. "These companion diagnostics are now approved to assess HER2-positive status in metastatic gastroesophageal adenocarcinoma patients, including those with gastric, gastroesophageal junction, and esophageal adenocarcinoma. The approval enables clinicians to identify HER2-positive GEA patients who may be eligible for HER2-targeted treatment with Jazz Pharmaceuticals' ZIIHERA. Two ZIIHERA-containing regimens are now FDA approved for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive GEA," Roche stated.
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