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Jazz Pharmaceuticals to Present Advancements in Solid Tumors and Blood Cancer Research at San Antonio Breast Cancer Symposium and American Society of Hematology Annual Meeting

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Jazz Pharmaceuticals (JAZZ) announced presentations at two major medical conferences: the 2024 San Antonio Breast Cancer Symposium (SABCS) and the 66th American Society of Hematology (ASH) Annual Meeting. At SABCS, the company will present two abstracts focusing on Ziihera® (zanidatamab-hrii), including a Phase 3 trial design and new data from a Phase 1b/2 study in HER2-positive breast cancer patients.

At ASH, Jazz will showcase 13 abstracts, primarily featuring research on Vyxeos® and Defitelio®. The presentations include multiple Phase 3 trials and studies examining various combination therapies for acute myeloid leukemia (AML) and other blood cancers. This extensive research portfolio demonstrates Jazz's commitment to advancing cancer treatment options.

Jazz Pharmaceuticals (JAZZ) ha annunciato presentazioni in due importanti conferenze mediche: il 2024 San Antonio Breast Cancer Symposium (SABCS) e il 66° Congresso Annuale della American Society of Hematology (ASH). Al SABCS, l'azienda presenterà due abstract focalizzati su Ziihera® (zanidatamab-hrii), inclusi il progetto di uno studio di fase 3 e nuovi dati da uno studio di fase 1b/2 in pazienti con cancro al seno HER2-positivo.

All'ASH, Jazz presenterà 13 abstract, concentrandosi principalmente sulla ricerca su Vyxeos® e Defitelio®. Le presentazioni includeranno diversi studi di fase 3 e ricerche che esaminano varie terapie di combinazione per la leucemia mieloide acuta (LMA) e altri tumori del sangue. Questo ampio portfolio di ricerche dimostra l'impegno di Jazz nell'avanzare le opzioni di trattamento per il cancro.

Jazz Pharmaceuticals (JAZZ) anunció presentaciones en dos importantes conferencias médicas: el 2024 San Antonio Breast Cancer Symposium (SABCS) y el 66º Congreso Anual de la American Society of Hematology (ASH). En SABCS, la compañía presentará dos resúmenes centrados en Ziihera® (zanidatamab-hrii), incluyendo el diseño de un ensayo de fase 3 y nuevos datos de un estudio de fase 1b/2 en pacientes con cáncer de mama HER2-positivo.

En ASH, Jazz presentará 13 resúmenes, enfocados principalmente en la investigación sobre Vyxeos® y Defitelio®. Las presentaciones incluirán múltiples ensayos de fase 3 y estudios que examinan varias terapias de combinación para la leucemia mieloide aguda (LMA) y otros cánceres de sangre. Este extenso portafolio de investigación demuestra el compromiso de Jazz por avanzar en las opciones de tratamiento del cáncer.

재즈 제약 (JAZZ)은 두 개의 주요 의학 회의에서 발표하겠다고 발표했습니다: 2024 샌안토니오 유방암 심포지엄 (SABCS)제66회 미국 혈액학회 연례 회의 (ASH). SABCS에서 이 회사는 Ziihera® (잔이다타맙-hrii)에 초점을 맞춘 두 개의 초록을 발표할 예정이며, 여기에는 3상 연구 설계와 HER2 양성 유방암 환자에 대한 1b/2상 연구에서의 새로운 데이터가 포함됩니다.

ASH에서 Jazz는 Vyxeos®Defitelio®에 관한 연구를 주로 다루는 13개의 초록을 전시합니다. 발표에는 여러 3상 연구와 급성 골수성 백혈병 (AML) 및 기타 혈액암에 대한 다양한 병용 요법을 검토하는 연구가 포함됩니다. 이 방대한 연구 포트폴리오는 암 치료 옵션을 발전시키려는 Jazz의 의지를 보여줍니다.

Jazz Pharmaceuticals (JAZZ) a annoncé des présentations lors de deux grandes conférences médicales : le 2024 San Antonio Breast Cancer Symposium (SABCS) et le 66e Congrès annuel de l'American Society of Hematology (ASH). Lors du SABCS, l'entreprise présentera deux résumés axés sur Ziihera® (zanidatamab-hrii), y compris un plan d'essai de phase 3 et de nouvelles données d'une étude de phase 1b/2 chez des patientes atteintes de cancer du sein HER2-positif.

Lors de l'ASH, Jazz présentera 13 résumés, principalement axés sur la recherche concernant Vyxeos® et Defitelio®. Les présentations comprendront plusieurs essais de phase 3 et des études examinant diverses thérapies combinées pour la leucémie myéloïde aiguë (LMA) et d'autres cancers du sang. Ce vaste portefeuille de recherche démontre l'engagement de Jazz à faire avancer les options de traitement du cancer.

Jazz Pharmaceuticals (JAZZ) gab bekannt, dass sie auf zwei wichtigen medizinischen Konferenzen präsentieren werden: dem 2024 San Antonio Breast Cancer Symposium (SABCS) und dem 66. Jahrestagung der American Society of Hematology (ASH). Beim SABCS wird das Unternehmen zwei Abstracts vorstellen, die sich auf Ziihera® (zanidatamab-hrii) konzentrieren, einschließlich eines Designs für eine Phase-3-Studie und neuen Daten aus einer Phase-1b/2-Studie bei HER2-positiven Brustkrebspatienten.

Bei der ASH wird Jazz 13 Abstracts präsentieren, die hauptsächlich Forschung zu Vyxeos® und Defitelio® beinhalten. Die Präsentationen umfassen mehrere Phase-3-Studien und Untersuchungen zu verschiedenen Kombinationstherapien für akute myeloische Leukämie (AML) und andere Blutkrankheiten. Dieses umfangreiche Forschungsportfolio zeigt Jazz' Engagement für die Weiterentwicklung der Krebstherapieoptionen.

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Data showcased at SABCS and ASH reflect progress and growth of Jazz's research and development in oncology and demonstrate ongoing efforts to redefine what is possible for cancer treatment

DUBLIN, Dec. 3, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company and its partners will present two abstracts at the 2024 San Antonio Breast Cancer Symposium (SABCS) from December 10-13 and 13 abstracts at the 66th Annual American Society of Hematology (ASH) Annual Meeting from December 7-10.

A trial-in-progress poster presentation at SABCS outlines the trial design of the ongoing Phase 3 EmpowHER-303 trial (NCT06435429), which is evaluating the efficacy and safety of Ziihera® (zanidatamab-hrii) vs trastuzumab with chemotherapy in patients with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, trastuzumab deruxtecan. New data from a Phase 1b/2 study of zanidatamab plus evorpacept (NCT05027139) in patients with pre-treated HER2-positive and HER2-low metastatic breast cancer will be featured as a poster spotlight.

"Following the recent FDA approval of Ziihera for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, we are pleased to present meaningful data at SABCS on the positive impact zanidatamab can have for patients with HER2-expressing cancers. We continue to advance our clinical program for zanidatamab with the goal to improve outcomes for patients with difficult-to-treat HER2-positive cancers. Our development program includes multiple ongoing Phase 3 trials evaluating 1L BTC, 1L GEA, with top-line PFS results expected in the second quarter of 2025, and metastatic breast cancer after T-DXd treatment, supporting the use of zanidatamab after other HER2-targeted therapies," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "Additionally, we look forward to highlighting 13 abstracts featuring oncology research at ASH 2024, which underscores our commitment to improving standards of care in blood cancer and other hematologic diseases."

The full SABCS abstracts are available here. The Jazz and partner-supported presentations at SABCS 2024 are:  

Ziihera® (zanidatamab-hrii) Presentations

Topic

Author

Presentation Details

EmpowHER 303: A phase 3 study to
evaluate the efficacy and safety of
zanidatamab vs trastuzumab with
chemotherapy in patients (pts) with
metastatic HER2-positive breast
cancer who have progressed on, or are
intolerant to, trastuzumab deruxtecan

Sara M Tolaney, et al.

Presentation Type: Poster Session

Abstract Number: SESS-1922

Date: Friday December 13, 2024

Time: 12:00-2:00 PM (PST)

Zanidatamab in combination with
evorpacept in HER2-positive and
HER2-low metastatic breast cancer:
Results from a phase 1b/2 study

Alberto J Montero, et al.

Presentation Type: Poster Spotlight Presentation

Abstract Number: SESS-2007

Date: Thursday December 12, 2024

Time: 7:00-8:30 AM (PST)

The full ASH abstracts are available here. The Jazz and partner-supported presentations at ASH 2024 are:  

Vyxeos® (daunorubicin and cytarabine) Presentations

Topic

Author

Presentation Details

A Randomized Comparison of CPX-
351 and FLAG-Ida in Patients With
High-Risk Acute Myeloid Leukemia
(AML)/Myelodysplastic Syndrome
(MDS) And MDS-Related Gene
Mutations: A Subgroup Analysis of the
UK NCRI AML19 Trial

Priyanka Mehta, et al.

Presentation Type: Oral Presentation

Abstract Number: #55

Date: Saturday December 7, 2024

Time: 9:30 AM (PST)

AML-MR Mutations Drive the Benefit of
CPX-351 over 7+3 in the Pivotal Phase
3 AML Trial

Shai O Shimony, et al.

Presentation Type: Oral Presentation

Abstract Number: #60

Date: Saturday December 7, 2024

Time: 10:45 AM (PST)

Phase Ib/II Study of CPX-351 in
Combination with Venetoclax in
Patients with Newly Diagnosed, High
Risk Acute Myeloid Leukemia

Emmanuel Almanza, et al.

Presentation Type: Poster Presentation

Abstract Number: #1511

Date: Saturday December 7, 2024

Time: 5:30-7:30 PM (PST)

A Randomised Comparison of CPX-
351 versus Standard Daunorubicin and
Cytarabine plus Fractionated
Gemtuzumab Ozogamicin in Older
AML Adults Without Known Adverse
Risk Cytogenetics: Results of the NCRI
AML18 Trial

Steven Knapper, et al.

Presentation Type: Oral Presentation

Abstract Number: #59

Date: Saturday December 7, 2024

Time: 10:30 AM (PST)

Phase 1/1b Dose Escalation and
Expansion of CPX-351 in Combination
with Gemtuzumab Ozogamicin in
Newly Diagnosed Acute Myeloid
Leukemia

Onyee Chan, et al.

Presentation Type: Poster Presentation

Abstract Number: #4270

Date: Monday December 9, 2024

Time:  6:00-8:00 PM (PST)

A Phase 3 Randomized Trial for
Patients with de novo AML Comparing
Standard Therapy Including
Gemtuzumab Ozogamicin (GO) to
CPX-351 with GO – A report from the
Children's Oncology Group

Jessica A Pollard, et al.

Presentation Type: Oral Presentation

Abstract Number: #967

Date: Monday December 9, 2024

Time: 4:30 PM (PST)

Combination of CPX-351 and
Gemtuzumab Ozogamicin (GO) in
Relapsed Refractory (R/R) Acute
Myeloid Leukemia and Post
Hypomethylating Agent (HMA) Failure
High-Risk Myelodysplastic Syndrome
(HR-MDS)

Jayastu Senapati, et al.

Presentation Type: Poster Presentation 

Abstract Number: #2903

Date: Sunday December 8, 2024

Time: 6:00-8:00 PM (PST)

Phase Ib/II Study of CPX-351 plus
Venetoclax in Patients with
Relapsed/Refractory Acute Myeloid
Leukemia (AML)

Vanthana Bharathi, et al.

Presentation Type: Poster Presentation

Abstract Number: #4272

Date: Monday December 9, 2024

Time: 6:00-8:00 PM (PST)

Rapid, Reliable, and Comprehensive
Identification of MDS-Defining
Cytogenetic Changes By a FISH-Panel
Containing Six Probes in a Real-World
Population of Patients with Suspected
AML

Katayoon Shirneshan, et al.

Presentation Type: Poster Presentation

Abstract Number: #4308

Date: Monday December 9, 2024

Time: 6:00-8:00 PM (PST)

Prospective Evaluation of the Impact of
Measurable Residual Disease (MRD)
by Error Corrected Next-Generation
Sequencing (NGS) with CPX-351 in
Acute Myeloid Leukemia (AML)

David Sallman, et al.

Presentation Type: Poster Presentation

Abstract Number: #4332

Date: Monday December 9, 2024

Time: 6:00-8:00 PM (PST)

A Phase 1 Study of CPX-351 Plus
Gilteritinib in Relapsed or Refractory,
FLT3-Mutated Acute Myeloid Leukemia

Onyee Chan, et al.

Presentation Type: Poster Presentation

Abstract Number: #1520

Date: Saturday December 7, 2024

Time:  5:30-7:30 PM (PST)

Defitelio® (defibrotide sodium) Presentations

Topic

Author

Presentation Details

Genetic Susceptibility in Sinusoidal
Obstruction Syndrome/Veno-Occlusive
Disease

Ioulia Mavrikou, et al.

Presentation Type: Poster presentation 

Abstract Number: #4778

Date: Monday December 9, 2024

Time:  6:00-8:00 PM (PST)

Defibrotide reduces hypercoagulable
state in patients with Sickle Cell
Disease-Related Acute Chest
Syndrome

Edo Schaefer, et al.

Presentation Type: Poster presentation

Abstract Number: #2515

Date: Sunday December 8, 2024

Time: 6:00-8:00 PM (PST)

About Ziihera® (zanidatamab-hrii) 

Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that binds to two extracellular sites on HER2. Binding of zanidatamab-hrii with HER2 results in internalization leading to a reduction of the receptor on the tumor cell surface. Zanidatamab-hrii induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and cell death in vitro and in vivo.1 In the United States, Ziihera is indicated for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 The U.S. Food and Drug Administration (FDA) granted accelerated approval for this indication based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).1

Zanidatamab is not approved anywhere else in the world.

Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.

The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer.

Important Safety Information for ZIIHERA®

WARNING: EMBRYO-FETAL TOXICITY

Exposure to ZIIHERA during pregnancy can cause embryo-fetal harm. Advise patients
of the risk and need for effective contraception.

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity
ZIIHERA can cause fetal harm when administered to a pregnant woman. In literature reports, use of a HER2-directed antibody during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Verify the pregnancy status of females of reproductive potential prior to the initiation of ZIIHERA. Advise pregnant women and females of reproductive potential that exposure to ZIIHERA during pregnancy or within 4 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment with ZIIHERA and for 4 months following the last dose of ZIIHERA.

Left Ventricular Dysfunction
ZIIHERA can cause decreases in left ventricular ejection fraction (LVEF). LVEF declined by >10% and decreased to <50% in 4.3% of 233 patients. Left ventricular dysfunction (LVD) leading to permanent discontinuation of ZIIHERA was reported in 0.9% of patients. The median time to first occurrence of LVD was 5.6 months (range: 1.6 to 18.7). LVD resolved in 70% of patients.

Assess LVEF prior to initiation of ZIIHERA and at regular intervals during treatment. Withhold dose or permanently discontinue ZIIHERA based on severity of adverse reactions.

The safety of ZIIHERA has not been established in patients with a baseline ejection fraction that is below 50%.

Infusion-Related Reactions
ZIIHERA can cause infusion-related reactions (IRRs). An IRR was reported in 31% of 233 patients treated with ZIIHERA as a single agent in clinical studies, including Grade 3 (0.4%), and Grade 2 (25%). IRRs leading to permanent discontinuation of ZIIHERA were reported in 0.4% of patients. IRRs occurred on the first day of dosing in 28% of patients; 97% of IRRs resolved within one day.

Prior to each dose of ZIIHERA, administer premedications to prevent potential IRRs. Monitor patients for signs and symptoms of IRR during ZIIHERA administration and as clinically indicated after completion of infusion. Have medications and emergency equipment to treat IRRs available for immediate use.

If an IRR occurs, slow, or stop the infusion, and administer appropriate medical management. Monitor patients until complete resolution of signs and symptoms before resuming. Permanently discontinue ZIIHERA in patients with recurrent severe or life-threatening IRRs.

Diarrhea
ZIIHERA can cause severe diarrhea.

Diarrhea was reported in 48% of 233 patients treated in clinical studies, including Grade 3 (6%) and Grade 2 (17%). If diarrhea occurs, administer antidiarrheal treatment as clinically indicated. Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea. Withhold or permanently discontinue ZIIHERA based on severity.

ADVERSE REACTIONS

Serious adverse reactions occurred in 53% of 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA. Serious adverse reactions in >2% of patients included biliary obstruction (15%), biliary tract infection (8%), sepsis (8%), pneumonia (5%), diarrhea (3.8%), gastric obstruction (3.8%), and fatigue (2.5%). A fatal adverse reaction of hepatic failure occurred in one patient who received ZIIHERA.

The most common adverse reactions in 80 patients with unresectable or metastatic HER2-positive BTC who received ZIIHERA (≥20%) were diarrhea (50%), infusion-related reaction (35%), abdominal pain (29%), and fatigue (24%).

USE IN SPECIFIC POPULATIONS

Pediatric Use
Safety and efficacy of ZIIHERA have not been established in pediatric patients.

Geriatric Use
Of the 80 patients who received ZIIHERA for unresectable or metastatic HER2-positive BTC, there were 39 (49%) patients 65 years of age and older. Thirty-seven (46%) were aged 65-74 years old and 2 (3%) were aged 75 years or older.

No overall differences in safety or efficacy were observed between these patients and younger adult patients.

About Vyxeos® (daunorubicin and cytarabine) liposome for injection
Vyxeos is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor. 

In the U.S., Vyxeos (daunorubicin and cytarabine) liposome for injection is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

More information about Vyxeos in the United States, including Full Prescribing Information and BOXED Warning, is available here

Important Safety Information for VYXEOS® 

WARNING: VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products. 

VYXEOS should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients. 

VYXEOS can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with VYXEOS. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding. 

VYXEOS can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as: 

  • shortness of breath or trouble breathing
  • swelling or fluid retention, especially in the feet, ankles, or legs
  • unusual tiredness

VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:

  • trouble breathing
  • severe itching
  • skin rash or hives
  • swelling of the face, lips, mouth, or tongue

VYXEOS contains copper and may cause copper overload in patients with Wilson's disease or other copper-processing disorders. 

VYXEOS can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site. 

VYXEOS can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving VYXEOS. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of VYXEOS. 

The most common side effects are bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting. 

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568. 

About Defitelio® (defibrotide sodium)
In the U.S., Defitelio® (defibrotide sodium) injection 80mg/mL received U.S. Food and Drug Administration (FDA) marketing approval on March 30, 2016, and it is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT) and is the first and only FDA-approved therapy for patients with this rare, potentially fatal complication.6 

Please see full Prescribing Information for Defitelio in the United States.

In Europe, defibrotide is marketed under the name Defitelio® ▼ (defibrotide). In October 2013, the European Commission granted marketing authorization to Defitelio under exceptional circumstances for the treatment of severe VOD in patients after HSCT therapy. In Europe, Defitelio is indicated in patients over one month of age.  

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system found under section 4.8 of the SmPC 

(https://www.ema.europa.eu/en/documents/product-information/defitelio-epar-product-information_en.pdf

The full Summary of Product Characteristics of Defitelio in Europe is available here

Important Safety Information for Defitelio®

Defitelio should not be given to patients who are: 

  • Currently taking anticoagulants or fibrinolytics 
  • Allergic to Defitelio or any of its ingredients 

Defitelio may increase the risk of bleeding in patients with VOD and should not be given to patients with active bleeding. During treatment with Defitelio, patients should be monitored for signs of bleeding. In the event that bleeding occurs during treatment with Defitelio, treatment should be temporarily or permanently stopped. 

Patients should tell the doctor right away about any signs or symptoms of hemorrhage such as unusual bleeding, easy bruising, blood in urine or stool, headache, confusion, slurred speech, or altered vision.  

Defitelio may cause allergic reactions including anaphylaxis. Patients who develop signs and symptoms of anaphylaxis such as trouble breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth or tongue should seek medical attention immediately. 

The most common side effects of Defitelio are decreased blood pressure, diarrhea, vomiting, nausea and nose bleeds. 

Defitelio is not approved for the prevention of VOD. It is not indicated in patients with hypersensitivity to defibrotide or any of its excipients or with concomitant use of thrombolytic therapy.  

About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Jazz Pharmaceuticals plc Caution Concerning Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to expectations of top-line PFS results in the second quarter of 2025 and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with pharmaceutical product development, and other risks and uncertainties affecting Jazz Pharmaceuticals and its development programs, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including Jazz Pharmaceuticals' Annual Report on Form 10-K for the year ended December 31, 2023, as supplemented by our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and future filings and reports by Jazz Pharmaceuticals. Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect Jazz Pharmaceuticals' forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise. Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

Contacts:

Jazz Media Contact:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948

Jazz Investor Contact:
Jeff Macdonald
Executive Director, Investor Relations
Jazz Pharmaceuticals plc
investorinfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717

Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

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SOURCE Jazz Pharmaceuticals plc

FAQ

What will Jazz Pharmaceuticals present at SABCS 2024?

Jazz Pharmaceuticals (JAZZ) will present two abstracts at SABCS 2024, including a Phase 3 EmpowHER-303 trial design for Ziihera and Phase 1b/2 study data of zanidatamab plus evorpacept in HER2-positive breast cancer patients.

How many abstracts will JAZZ present at ASH 2024?

Jazz Pharmaceuticals will present 13 abstracts at the ASH 2024 Annual Meeting, primarily focusing on Vyxeos and Defitelio research in blood cancers and related conditions.

When are the top-line PFS results expected for JAZZ's zanidatamab trials?

The top-line PFS results for Jazz Pharmaceuticals' zanidatamab trials in 1L BTC and 1L GEA are expected in the second quarter of 2025.

What is the focus of JAZZ's EmpowHER-303 trial?

The EmpowHER-303 trial evaluates Ziihera versus trastuzumab with chemotherapy in patients with metastatic HER2-positive breast cancer who have progressed on or are intolerant to trastuzumab deruxtecan.

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