Welcome to our dedicated page for Jazz Pharmaceuticals news (Ticker: JAZZ), a resource for investors and traders seeking the latest updates and insights on Jazz Pharmaceuticals stock.
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 (Nasdaq: JAZZ) reported Q2 2021 total revenues of $751.8 million, a 34% increase from Q2 2020. GAAP net loss was $363.3 million ($6.11 per share), while non-GAAP adjusted net income was $240.6 million ($3.90 per share). Net product sales of Xywav reached $124.2 million, significantly boosting the oxybate business. The company reaffirms 2021 revenue guidance of $3.02 billion to $3.18 billion. The GW acquisition strengthens R&D and commercial capabilities. Upcoming product launches include Xywav for idiopathic hypersomnia, enhancing growth prospects.
Jazz Pharmaceuticals (Nasdaq: JAZZ) announced that Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) has been added to the NCCN Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (ALL). This inclusion benefits both pediatric and adult patients who are hypersensitive to E. coli-derived asparaginase. Rylaze, FDA-approved on June 30, 2021, addresses the significant need for an effective asparaginase treatment. The NCCN Guidelines aid in treatment decision-making globally, enhancing patient care.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced it will release its 2021 second quarter financial results on August 3, 2021, after market close. Following the release, management will conduct a live audio webcast at 4:30 p.m. ET, discussing financial results and offering updates. Dial-in details are provided for both U.S. and international listeners. A replay of the conference call will be available until August 10, 2021. The company is dedicated to developing innovative treatments for serious diseases and has a diverse portfolio in neuroscience and oncology.
Jazz Pharmaceuticals (Nasdaq: JAZZ) will host a webcast on July 20, 2021, at 4:30 p.m. ET to discuss the recent FDA approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), which occurred on June 30, 2021. This drug is intended for patients with acute lymphoblastic leukemia (ALL) who are hypersensitive to E. coli-derived asparaginase. The event aims to provide insights into the drug's commercial launch and the ongoing need for alternative asparaginase treatments. The webcast will be accessible through Jazz's investor site.
Jazz Pharmaceuticals has received FDA approval for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients with hypersensitivity to E. coli-derived asparaginase. This unique recombinant product maintains active levels throughout treatment and addresses urgent patient needs. Rylaze is expected to be available in mid-July 2021. The approval, part of the Real-Time Oncology Review program, is based on positive clinical trial data, ensuring reliable supply for patients.
The U.S. FDA has granted Xywav seven years of Orphan Drug Exclusivity for treating cataplexy and excessive daytime sleepiness in patients aged 7 and older with narcolepsy. This drug features a unique composition that provides 92% less sodium than the previous treatment, Xyrem. The FDA cites Xywav's clinical superiority due to its greater safety profile, potentially reducing cardiovascular risks for patients. The exclusivity period began on July 21, 2020, following FDA approval.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has updated its full-year 2021 financial guidance following the acquisition of GW Pharmaceuticals on May 5, 2021. The new guidance anticipates revenues of $3,020 - $3,180 million, boosting predictions for strong product growth, especially for Epidiolex. The company expects accelerated revenue diversification with double-digit growth and non-GAAP EPS accretion starting in the first full year post-acquisition. However, the acquisition also brings increased expenses and potential dilution concerns that could impact 2021 earnings per share.
Jazz Pharmaceuticals (Nasdaq: JAZZ) launched the Nothing Small About It program, a dedicated online hub for small cell lung cancer (SCLC) patients and caregivers. Developed in collaboration with notable cancer organizations, this platform aims to address the emotional, social, and physical health needs of those affected by SCLC. The initiative offers user-friendly resources, interactive content, and personal stories to empower patients and caregivers. Approximately 30,000 to 35,000 new SCLC cases are reported annually in the U.S. The program aims to enhance awareness and support for the SCLC community.
Jazz Pharmaceuticals announced the presentation of 13 abstracts at SLEEP 2021, the 35th annual meeting of the Associated Professional Sleep Societies, from June 10-13, 2021. Highlights include a late-breaking abstract on Xywav’s effects on idiopathic hypersomnia and results from studies on narcolepsy and Sunosi. CEO Robert Iannone emphasized the company’s commitment to addressing unmet needs in sleep disorders. However, Xywav is not yet approved for treating idiopathic hypersomnia, raising questions about its market potential.
Jazz Pharmaceuticals (Nasdaq: JAZZ) will present at the Jefferies Virtual Healthcare Conference on June 2, 2021, at 1:00 p.m. ET. The management team will discuss the company's business and financial updates. The live webcast will be accessible on the Jazz Pharmaceuticals website, with a replay available for one week.
Jazz Pharmaceuticals is a global biopharmaceutical company focused on developing innovative medicines for patients with serious diseases.
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