Jazz Pharmaceuticals(JAZZ)
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Jazz Pharmaceuticals (NasdaqGS:JAZZ) FY Earnings Call Presentation
2026-01-13 19:15
January 2026 44th Annual J.P. Morgan Healthcare Conference Redefining Possibilities in Rare Disease Renee Gala, President & CEO Transforming Lives. Redefining Possibilities. Caution Concerning Forward-Looking Statements This presentation contains forward-looking statements and financial targets, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the ability of the Company's portfolio to drive long-term shareholder value; ...
Jazz Pharmaceuticals price target raised to $235 from $210 at Needham
Yahoo Finance· 2026-01-13 12:43
Core Viewpoint - Needham analyst Ami Fadia has raised the price target for Jazz Pharmaceuticals (JAZZ) to $235 from $210 while maintaining a Buy rating on the shares, indicating positive sentiment towards the company's future performance [1]. Group 1: Study Insights - The company presented the HERIZON-GEA-01 study with additional details on subgroup analysis, showing that overall data favored zani treatment arms across all subgroups [1]. - The study indicated a longer progression-free survival (PFS) for the tislelizumab arm and slightly higher efficacy in TAP under 1% compared to TAP at 1% or higher [1]. Group 2: Expert Opinions - A key opinion leader noted that the benefits demonstrated by zani are "practice-changing," suggesting that zanidatamab plus chemotherapy with tislelizumab is expected to quickly replace the current standard of care [1].
Jazz Pharmaceuticals(JAZZ) - 2025 Q4 - Annual Results
2026-02-24 21:07
Revenue Guidance - Jazz Pharmaceuticals expects to meet its previously announced total revenue guidance range for the year ended December 31, 2025[4] - The company will provide specific revenue expectations for its products Xywav, Epidiolex, and Modeyso for the year ended December 31, 2025[4] Corporate Events - The corporate overview and financial update will be presented at the J.P. Morgan Healthcare Conference on January 13, 2026[4]
Boehringer Ingelheim announces clinical collaboration with Jazz Pharmaceuticals to advance HER2-targeted therapy in breast cancer
Globenewswire· 2026-01-12 12:05
Core Insights - Boehringer Ingelheim and Jazz Pharmaceuticals have announced a strategic clinical collaboration to explore a novel combination therapy for HER2-positive breast cancer patients, initiating a Phase 1b cohort within Boehringer's ongoing Beamion-BCGC1 trial [1][2] Group 1: Collaboration and Objectives - The collaboration aims to improve patient outcomes by combining zongertinib and zanidatamab, potentially offering a new therapeutic option for patients with HER2-positive breast cancer [2][3] - The research collaboration is focused on transforming treatment paradigms in HER2-expressing breast cancer through the investigation of this novel HER2-targeted combination therapy [3] Group 2: Product Information - Zongertinib (HERNEXEOS®) has received FDA accelerated approval in the U.S., conditional approval in China, and marketing authorization in Japan for previously treated patients with HER2-mutant advanced non-small cell lung cancer (NSCLC), demonstrating an objective response rate (ORR) of 71% in pre-treated patients [3][4] - Zanidatamab (ZIIHERA®), a bispecific HER2-directed antibody, has received accelerated approval from the U.S. FDA for the treatment of adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer and is currently in Phase III trials for various cancers [4] Group 3: Future Directions - The companies anticipate that the study will generate critical insights into the safety and efficacy of dual HER2 blockade, informing the development of a potential future combination therapy [5]
Jazz Pharmaceuticals plc (JAZZ) Discusses HERIZON-GEA-01 Phase III Trial Results for Zanidatamab in HER2+ GEA Transcript
Seeking Alpha· 2026-01-09 19:24
Core Viewpoint - Jazz Pharmaceuticals presented groundbreaking data from the Phase III HERIZON-GEA-01 clinical trial for zanidatamab in combination with chemotherapy for first-line HER2-positive GEA patients at a recent symposium [2]. Group 1: Clinical Trial Insights - The HERIZON-GEA-01 trial assesses zanidatamab in combination with chemotherapy, with or without tislelizumab, targeting first-line HER2-positive GEA patients [2][3]. - The presentation of the trial data occurred at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium, highlighting the significance of the findings [2]. Group 2: Leadership and Expertise - Dr. Geoff Ku, an associate attending physician at Memorial Sloan Kettering Cancer Center, participated in the call to discuss the HERIZON data, indicating the involvement of leading experts in the field [3].
Jazz Pharmaceuticals: A Strong Buy Due To Execution In Oncology (NASDAQ:JAZZ)
Seeking Alpha· 2026-01-09 18:46
Core Insights - The article highlights the background and expertise of Brendan, who has a strong foundation in organic synthesis and experience in both pharmaceutical and biotech sectors [1] Group 1: Background and Experience - Brendan completed a Ph.D. at Stanford University in organic synthesis in 2009 [1] - He worked for Merck, a major pharmaceutical company, from 2009 to 2013 [1] - Brendan has experience in biotech startups, including Theravance and Aspira, before joining Caltech [1] Group 2: Entrepreneurial Ventures - He was the first employee and co-founder of 1200 Pharma, which spun out of Caltech and secured significant investment in the 8 figures [1] - Brendan remains an avid investor, focusing on market trends, particularly in biotechnology stocks [1]
Jazz Pharmaceuticals: A Strong Buy Due To Execution In Oncology
Seeking Alpha· 2026-01-09 18:46
Core Insights - The article highlights the professional background of Brendan, who has extensive experience in the pharmaceutical and biotechnology sectors, including a Ph.D. from Stanford and roles at major companies like Merck and start-ups [1] Group 1: Professional Background - Brendan completed a Ph.D. in organic synthesis at Stanford University in 2009 [1] - He worked for Merck from 2009 to 2013, gaining significant experience in the pharmaceutical industry [1] - Brendan has been involved in biotech start-ups, including Theravance and Aspira, before joining Caltech [1] Group 2: Entrepreneurial Ventures - He was the first employee and co-founder of 1200 Pharma, which spun out of Caltech and secured major investments in the eight-figure range [1] - Brendan remains an active investor, focusing on market trends, particularly in biotechnology stocks [1]
Jazz Pharmaceuticals (NasdaqGS:JAZZ) Update / Briefing Transcript
2026-01-09 15:32
Summary of Jazz Pharmaceuticals Investor Call on Zanidatamab Horizon-GEA-01 Company and Industry - **Company**: Jazz Pharmaceuticals (NasdaqGS:JAZZ) - **Industry**: Oncology, specifically focusing on HER2-positive gastroesophageal adenocarcinoma (GEA) Core Points and Arguments 1. **Clinical Trial Presentation**: Jazz Pharmaceuticals presented data from the phase III Horizon-GEA-01 Clinical Trial at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium, focusing on zanidatamab in combination with chemotherapy for HER2-positive GEA patients [2][4] 2. **Efficacy of Zanidatamab**: The trial demonstrated a 35% reduction in the risk of disease progression or death, translating to over four months of improvement in median progression-free survival (PFS) compared to trastuzumab plus chemotherapy [7][24] 3. **Overall Survival Benefits**: There was a statistically significant 28% reduction in the risk of death for zanidatamab plus tislelizumab plus chemotherapy versus trastuzumab, leading to a more than seven-month improvement in median overall survival (OS) [8][24] 4. **Mechanism of Action**: Zanidatamab is a bispecific antibody targeting two extracellular domains of HER2, which differentiates it from traditional therapies and enhances its efficacy [22][23] 5. **Safety Profile**: The safety profile of zanidatamab was consistent with known profiles of the individual treatments, although there was an increase in grade three or more toxicities in zanidatamab-containing arms [18][19] 6. **Regulatory Plans**: Jazz Pharmaceuticals plans to submit a supplemental biologics license application in the first half of the year and seeks inclusion in NCCN guidelines based on the trial results [21][33] Additional Important Content 1. **Patient Demographics**: The trial included 914 patients, with approximately 50% enrolled from Asia and 80%-85% of tumors being HER2 IHC3+ [12][13] 2. **Adverse Events**: Infusion-related reactions occurred in 25% of patients receiving zanidatamab, compared to 13.2% for trastuzumab, indicating a need for careful monitoring [18] 3. **Market Opportunity**: GEA is the fifth most common cancer globally, with a significant unmet need for effective HER2-targeted therapies, as the last new option was introduced in 2010 [30][31] 4. **Commercial Strategy**: Jazz Pharmaceuticals is positioned to leverage existing infrastructure for a rapid launch of zanidatamab if approved, with a focus on the strong data supporting its efficacy [31][32] 5. **Future Development**: The company is exploring zanidatamab in various HER2-positive solid tumors, indicating a robust pipeline and potential for broader applications [29][28] This summary encapsulates the key points discussed during the investor call, highlighting the promising data for zanidatamab and its potential impact on the treatment landscape for HER2-positive GEA.
Jazz Pharmaceuticals (NasdaqGS:JAZZ) Earnings Call Presentation
2026-01-09 14:30
January 9, 2026 Zanidatamab: Pivotal Phase 3 HERIZON-GEA-01 Trial Results in Gastroesophageal Adenocarcinoma (GEA) Innovating to Transform the Lives of Patients and Their Families Intended for U.S. investor audiences only. Intended for U.S. investor audiences only. 2 January 9, 2026 Transforming Lives. Redefining Possibilities. Caution Concerning Forward-Looking Statements This presentation contains forward-looking statements and financial targets, including, but not limited to, statements related to: the C ...
Ziihera® (zanidatamab-hrii) Combinations Achieve Unprecedented Results in First-Line HER2+ Locally Advanced or Metastatic GEA Including More Than Two Years Median Overall Survival Benefit
Prnewswire· 2026-01-06 18:32
Core Insights - The Phase 3 HERIZON-GEA-01 trial results indicate that Ziihera (zanidatamab-hrii) in combination with chemotherapy, with or without tislelizumab, is positioned to become the new standard of care for HER2-positive first-line metastatic gastroesophageal adenocarcinoma (GEA) [1][2][4] Efficacy Summary - The trial achieved a median overall survival (OS) of 26.4 months for Ziihera plus tislelizumab and chemotherapy, which is the longest reported in a Phase 3 trial for this indication, showing a greater than seven-month improvement compared to the control arm [2][4][5] - Median progression-free survival (PFS) was over one year, with a 35% reduction in the risk of disease progression or death compared to trastuzumab plus chemotherapy, representing a more than four-month improvement [4][5] - The objective response rate (ORR) was 70.7% for Ziihera plus tislelizumab and chemotherapy, compared to 65.7% for the control arm [5] Safety Profile - The safety profile of Ziihera in combination with chemotherapy was consistent with known effects of HER2-directed therapy, with no new safety signals identified [6][7] - Grade 3 treatment-related adverse events (TRAEs) were reported at 71.8% for Ziihera plus tislelizumab and chemotherapy, and 59.0% for Ziihera plus chemotherapy [6] - The most common Grade 3 TRAE was diarrhea, occurring in 24.5% of patients receiving Ziihera plus tislelizumab and chemotherapy [6] Future Developments - Jazz Pharmaceuticals plans to submit Ziihera for FDA approval based on these results and is also evaluating Ziihera in other HER2-driven tumor types, including HER2-positive metastatic breast cancer [7][8] - An investor webcast is scheduled to discuss the Ziihera data presented at the ASCO GI symposium [8] Trial Details - The HERIZON-GEA-01 trial was a global, randomized, open-label study involving 914 patients across more than 30 countries, comparing Ziihera plus chemotherapy (with or without tislelizumab) to trastuzumab plus chemotherapy [9]