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Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) is a global biopharmaceutical company dedicated to improving patients' lives by identifying, developing, and commercializing meaningful products that address unmet medical needs. Headquartered in Dublin, Ireland, with U.S. offices in Palo Alto, CA, and Philadelphia, PA, Jazz Pharmaceuticals employs over 875 people worldwide, fostering a highly collaborative and entrepreneurial culture.
Core Business: Jazz Pharmaceuticals focuses on three main therapeutic areas: sleep, hematology/oncology, and pain. The company's diverse product portfolio includes nine approved therapies across neuroscience and oncology indications. Notable products include Xyrem and Xywav for narcolepsy, Zepzelca for metastatic small cell lung cancer, Rylaze for acute lymphoblastic leukemia, Vyxeos for acute myeloid leukemia, and Epidiolex for severe forms of epilepsy, acquired through the purchase of GW Pharmaceuticals in May 2021.
Recent Achievements: In 2023, Jazz Pharmaceuticals reported strong financial performance, achieving over $3.8 billion in total revenue. The company also completed enrollment for a Phase 3 trial of Zepzelca in first-line small cell lung cancer and advanced several late-stage pipeline projects. In May 2024, the U.S. FDA accepted the Biologics License Application (BLA) for zanidatamab, a HER2-targeted bispecific antibody, with a Priority Review designation for treating biliary tract cancer.
Current Projects: Jazz Pharmaceuticals remains committed to expanding its product portfolio through R&D and strategic acquisitions. Ongoing projects include the development of zanidatamab for multiple HER2-expressing cancers, the Phase 3 trial for the combination of zanidatamab with standard chemotherapy for advanced gastric cancer, and the optimization of Epidiolex for broader epilepsy indications.
Financial Condition: As of December 31, 2023, Jazz Pharmaceuticals reported cash and cash equivalents of $1.6 billion. The company sustained a strong operational cash flow, generating $1.09 billion in 2023. Despite an outstanding long-term debt of $5.8 billion, Jazz's disciplined capital allocation supports continued investment in growth and innovation.
Partnerships: The company has key collaborations with various organizations, including BeiGene, Ltd. for the development of zanidatamab. Additionally, Jazz Pharmaceuticals has a strategic partnership with Life Science Cares to drive social impact through employee volunteerism in the U.S., reinforcing its commitment to community engagement.
Jazz Pharmaceuticals continues to innovate and advance its mission to transform lives through pioneering therapeutics in oncology and neuroscience, positioning itself as a leader in addressing complex and unmet medical needs.
Jazz Pharmaceuticals (JAZZ) has submitted a Supplemental Biologics License Application (sBLA) to the FDA for a Monday/Wednesday/Friday (M/W/F) dosing schedule of Rylaze™ for treating acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients with hypersensitivity to E. coli-derived asparaginase. This submission follows Rylaze's initial approval in June 2021 and aims to enhance patient treatment options. The sBLA supports ongoing clinical trial data showing a positive benefit-to-risk profile for Rylaze’s new dosing regimen, which maintains crucial serum asparaginase activity levels.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has unveiled its Vision 2025, aiming for $5 billion in revenue by 2025, approval of at least five new products by decade's end, and a 5% improvement in adjusted operating margin. The company anticipates meeting its 2021 revenue guidance of $3.02 to $3.1 billion. In 2021, Jazz successfully launched five key products and integrated GW Pharmaceuticals. The strategy focuses on diversifying revenue, with an expected 65% of 2022 revenue coming from new products. Jazz also targets a net leverage ratio below 3.5x by the end of 2022.
Jazz Pharmaceuticals (JAZZ) reported positive Phase 3 trial results for Xywav, an oral solution approved for treating idiopathic hypersomnia in adults, published in The Lancet Neurology. The trial showed statistically significant improvements in the Epworth Sleepiness Scale (ESS) scores versus placebo. Participants on Xywav maintained low ESS scores (mean 7.0) compared to placebo (mean 13.3). The FDA granted seven years of Orphan Drug Exclusivity for this indication. Xywav is now a key treatment option for approximately 37,000 diagnosed adult patients in the U.S., reflecting significant market potential.
Jazz Pharmaceuticals (Nasdaq: JAZZ) will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, from 2:15 – 2:55 p.m. ET. Bruce Cozadd, chairman and CEO, will lead the presentation. Interested parties can access a live audio webcast through the Investors section of Jazz Pharmaceuticals' website. A replay will be available for 30 days post-event. Jazz Pharmaceuticals is dedicated to developing transformative medicines for serious diseases and operates globally, serving patients in nearly 75 countries.
On January 3, 2022, Jazz Pharmaceuticals announced that the FDA granted Orphan Drug Exclusivity for Xywav for treating idiopathic hypersomnia in adults, marking the second exclusivity for this drug. Approved initially on August 12, 2021, Xywav offers seven years of market exclusivity. Idiopathic hypersomnia affects approximately 37,000 adults in the U.S. This designation highlights Jazz's commitment to developing new medicines for conditions with limited options.
Jazz Pharmaceuticals (Nasdaq: JAZZ) has initiated a Phase 2 clinical trial for JZP150, a novel small molecule treatment for adults with post-traumatic stress disorder (PTSD). Enrolling 270 participants across 40 U.S. sites, the trial aims to evaluate JZP150's safety and efficacy, supported by Fast Track designation from the FDA. This designation highlights the urgent need for effective PTSD treatments, as existing options often fall short. JZP150 could address significant unmet medical needs in PTSD treatment by targeting the underlying biology of the disorder.
Jazz Pharmaceuticals (NASDAQ: JAZZ) has initiated a global Phase 2b clinical trial for suvecaltamide (JZP385), targeting adults with moderate to severe essential tremor (ET). The trial, featuring a double-blind, placebo-controlled design, will enroll 400 participants across 50 sites in the U.S., U.K., and EU. Patients will receive doses of suvecaltamide or placebo for 12 weeks, with efficacy measured by the Tremor Research Group Essential Tremor Rating Assessment Scale. Results are expected in the first half of 2024, marking a critical step in addressing a long-standing unmet need for ET therapies.
PharmaMar and Jazz Pharmaceuticals have initiated a confirmatory Phase 3 trial, named LAGOON, for Zepzelca (lurbinectedin) to treat relapsed small cell lung cancer (SCLC). The trial, which will enroll 705 patients across over 100 sites mainly in North America and Europe, aims to demonstrate overall survival and progression-free survival outcomes. If successful, LAGOON could support full regulatory approval in the U.S. and marketing authorization in Europe. Zepzelca, previously approved under accelerated conditions, is seen as a critical treatment option for SCLC patients.
Jazz Pharmaceuticals announced initial positive results from a Phase 2/3 trial of Rylaze™ (asparaginase erwinia chrysanthemi) for adults and children with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginase. Conducted with the Children's Oncology Group, the trial evaluated different dosing schedules, showing a favorable safety profile and clinically meaningful serum asparaginase activity levels. Initial results will guide regulatory filings, including a supplemental Biologics Licensing Application for a new dosing schedule in early 2022.
Jazz Pharmaceuticals (Nasdaq: JAZZ) announced the presentation of six studies on Epidiolex (cannabidiol) at the upcoming 2021 American Epilepsy Society meeting from December 3-7 in Chicago, IL. This marks the first presentation following the integration of GW Pharmaceuticals. Key findings from a U.S.-based caregiver survey indicate improvements in emotional functioning, cognition, and a reduction in seizure frequency for patients with Lennox-Gastaut and Dravet syndromes. The company aims to enhance its neuroscience R&D portfolio to treat additional neurological conditions.
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