Jazz Pharmaceuticals Plc Stock Price, News & Analysis

Jazz Pharmaceuticals and PharmaMar will present new data for Zepzelca™ (lurbinectedin) at the IASLC 2020 North America Conference on Lung Cancer from October 16-17, 2020. The focus will be on outcomes from the Phase 2 basket trial in small cell lung cancer (SCLC), highlighting patients suitable for platinum re-challenge and those who demonstrated a response. Zepzelca is FDA-approved for metastatic SCLC after platinum-based chemotherapy. Continued approval may depend on further clinical validation.

On October 8, 2020, Jazz Pharmaceuticals announced positive top-line results from a Phase 3 study of Xywav (calcium, magnesium, potassium, sodium oxybates) in adults with idiopathic hypersomnia. The study showed significant improvements in excessive daytime sleepiness, with a p-value <0.0001 for key endpoints, including the Epworth Sleepiness Scale. There were no new safety concerns reported. Jazz plans to submit the data for FDA approval as a supplemental New Drug Application in early 2021, following the Fast Track designation granted in September 2020.

Jazz Pharmaceuticals (Nasdaq: JAZZ) has launched the Find the Right Fit program, aimed at educating patients about secondary acute myeloid leukemia (sAML) and myelodysplastic syndromes (MDS). Developed with the MDS Foundation and Cancer Support Community, this initiative provides valuable resources like articles, videos, and patient stories to help those newly diagnosed. The program emphasizes the criticality of education in managing treatment options for patients facing the challenges of sAML, which comprises about 30% of AML cases.

Jazz Pharmaceuticals (Nasdaq: JAZZ) has announced its partnership with the American Heart Association to improve sleep health through educational content. This initiative aims to combat the prevalent issue of inadequate sleep among Americans, which affects overall health and increases the risk of cardiometabolic diseases. Jazz's financial backing will support the development of multimedia resources, including podcasts dedicated to sleep disorders and their associated comorbidities. This collaboration aligns with Jazz's commitment to enhancing public health and well-being.

Jazz Pharmaceuticals has entered a new research collaboration with Redx Pharma to develop drug candidates targeting the Ras/Raf/MAPK cancer pathway. Jazz plans to pay Redx $10 million upfront and an additional $10 million in the second year, contingent on the ongoing research. Following the development of an IND-ready molecule, Redx could receive up to $200 million in milestone payments, along with royalties on future sales. This initiative strengthens Jazz's oncology pipeline as they strategically target cancer treatments.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced participation in three virtual investor conferences. Morgan Stanley Global Healthcare Conference will be held on September 15, 2020, featuring CEO Bruce Cozadd. The Cantor Global Healthcare Conference follows on September 16, 2020, also with Cozadd. Lastly, the BofA Global Healthcare Conference on September 18, 2020 will have President Daniel Swisher presenting. Live webcasts will be accessible on the company website, with archives available for a week post-event.

Jazz Pharmaceuticals announced the presentation of 10 abstracts at Virtual SLEEP 2020, the annual meeting of the Associated Professional Sleep Societies, from August 28-30. These presentations showcase significant advancements in sleep medicine, particularly research related to Xywav™ (JZP-258), aimed at treating narcolepsy. Key highlights include studies on health-related quality of life and dose titration in narcolepsy patients. The event features ongoing research on innovative therapies for chronic sleep disorders, emphasizing Jazz's commitment to improving patient outcomes.

Jazz Pharmaceuticals announced its Q2 2020 financial results, showcasing a total revenue increase of 5% year-over-year to $562.4 million. Key highlights included a net income of $114.8 million, though down from $261.9 million in Q2 2019. The company reported strong sales in its neuroscience segment, with Xyrem sales rising 8% to $446.8 million. The FDA approval of Xywav and successful launch of Zepzelca within six months were pivotal moments. Additionally, Jazz updated its financial guidance, projecting 2020 revenues between $2.225 billion and $2.325 billion, marking an increase from earlier estimates.

Jazz Pharmaceuticals announced the FDA approval of Xywav on July 21, 2020, for treating cataplexy and excessive daytime sleepiness (EDS) in patients with narcolepsy aged 7 and older. Xywav features a unique formulation with 92% less sodium than standard sodium oxybate, which may help patients comply with daily sodium intake recommendations. The approval is based on a Phase 3 clinical study involving 201 patients, showing significant efficacy in reducing cataplexy attacks and improving sleepiness scores. Xywav will launch by the end of the year following implementation of a Risk Evaluation and Mitigation Strategy (REMS).