$250.680
+6.292 (+2.51%)Zum Schluss
JAZZ-News
JAZZ-Events
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.
BeOne Medicines' TEVIMBRA Approved by FDA for HER2 Positive Gastric Cancer
BeOne Medicines (ONC) announced that the U.S. FDA has approved the supplemental Biologics License Application for TEVIMBRA in combination with ZIIHERA and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma. The approval is supported by results from the Phase 3 HERIZON-GEA-01 trial, which were published in The New England Journal of Medicine earlier this year. The approval is based on data from HERIZON-GEA-01, the global Phase 3 clinical trial evaluating ZIIHERA plus chemotherapy, with and without TEVIMBRA, compared with trastuzumab plus chemotherapy as first-line treatment for advanced or metastatic HER2+ GEA. Key findings from the trial include: Overall survival: TEVIMBRA plus ZIIHERA and chemotherapy demonstrated a statistically significant improvement in OS, with median OS of 26.4 months compared with 19.2 months in the control arm. Progression-free survival: TEVIMBRA plus ZIIHERA and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS, with a median PFS of 12.4 months compared with 8.1 months in the control arm.
Zymeworks' Partner Jazz Receives FDA Approval for Ziihera Regimens
Zymeworks (ZYME) announced that its partner, Jazz Pharmaceuticals, has received U.S. Food and Drug Administration approval for two Ziihera-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma: Ziihera plus Tevimbra and fluoropyrimidine- and platinum-containing chemotherapy, and Ziihera plus fluoropyrimidine- and platinum-containing chemotherapy. This is the second FDA approval for zanidatamab in less than two years, further validating Zymeworks' proprietary Azymetric platform and its ability to discover and develop differentiated multifunctional antibodies for patients with difficult-to-treat cancers. The FDA approval of zanidatamab in GEA following its accelerated approval in biliary tract cancer, and with additional clinical trials underway by Jazz Pharmaceuticals (JAZZ) and BeOne Medicines (ONC) across other tumor types, together underscores the potential of Zymeworks' partnered drug development and royalty strategy to expand the potential reach of this important medicine to more patients across multiple tumor types. Each additional indication has the potential to increase the clinical impact of zanidatamab, while creating incremental value through our royalty interest and commercial milestone payments. "We believe this approach of supporting the development of innovative medicines while leveraging the resources and expertise of our partners, provides a capital-efficient pathway to participate in long-term patient benefit, and value creation for our shareholders." The approval is supported by results from the Phase 3 HERIZON-GEA-01 trial, which demonstrated the benefit of zanidatamab in combination with immunotherapy and chemotherapy in the first-line treatment of HER2+ GEA. Results from the study were published in the New England Journal of Medicine and first presented at ASCO GI 2026. The trial remains ongoing, with additional analyses planned. Under the terms of its collaboration with Jazz Pharmaceuticals, Zymeworks has earned a $250M milestone payment upon this approval, bringing total upfront and milestone payments received from Jazz to $650M. The company remains eligible to receive up to $1.3B in additional regulatory and commercial milestones, as well as tiered royalties of 10% to 20% on Jazz's net sales of zanidatamab in Jazz's licensed territories. Separately, under its collaboration with BeOne Medicines, Zymeworks has received $81M in upfront and milestone payments to date and remains eligible for up to $144M in additional milestones, plus tiered royalties of up to 19.5% on net sales in BeOne's licensed territories. Together, these collaborations provide significant non-dilutive capital and long-term royalty potential, supporting Zymeworks' disciplined capital allocation strategy, including investment in its wholly-owned R&D pipeline, strategic business development opportunities, and return of capital to shareholders.
Diese Seite dient nur der Recherche und ist keine Anlageberatung. Modelle können falsch liegen. Vergangene Wertentwicklung ist kein Indikator für die Zukunft.