Jazz Pharmaceuticals Plc Stock Price, News & Analysis

Jazz Pharmaceuticals has secured exclusive rights to develop and commercialize zanidatamab, a HER2-targeted bispecific antibody, from Zymeworks in major markets including the U.S., Europe, and Japan. Zymeworks will receive an upfront payment of $50 million, with the potential for total payments reaching $1.76 billion upon meeting various milestones. Zanidatamab, currently in pivotal trials for HER2-expressing biliary tract cancer and gastroesophageal adenocarcinoma, has received Breakthrough Therapy designation from the FDA, underscoring its potential in oncology.

Jazz Pharmaceuticals (Nasdaq: JAZZ) is set to present seven abstracts at the 35th annual Psych Congress 2022 from September 17-20. The presentations highlight Jazz's leadership in sleep medicine, showcasing research on Xywav, a lower-sodium oxybate approved for treating narcolepsy and idiopathic hypersomnia. Key data include efficacy results from studies like TENOR and SEGUE, focusing on narcolepsy patients transitioning to Xywav. Jazz's commitment to innovation is underscored by its FDA-approved therapies, enhancing options for patients with debilitating sleep disorders.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) will participate in two upcoming investor conferences in September 2022. The Citi's 17th Annual BioPharma Conference is scheduled for September 7, 2022, at 1:00 p.m. ET. The Wells Fargo Healthcare Conference will follow on September 8, 2022, at 11:00 a.m. ET. Audio webcasts of both presentations will be available on the Jazz Pharmaceuticals website and will be archived for 30 days.

Jazz Pharmaceuticals has initiated a Phase 3 trial to study the safety and efficacy of Epidiolex (cannabidiol) for treating Epilepsy with Myoclonic-Atonic Seizures (EMAS). This is the first randomized, controlled trial focusing on this condition among children and adolescents. The trial will follow a double-blind, placebo-controlled design over 14 weeks, involving participants aged 1-18 from 30 global sites. Currently, Epidiolex is not approved for EMAS in the U.S. or EU. The study aims to address the need for effective treatments for treatment-resistant epilepsy syndromes.

Jazz Pharmaceuticals reported strong Q2 2022 results with total revenues of $932.9 million, a 24% increase year-over-year. The company affirmed its 2022 revenue guidance of $3.5 to $3.7 billion. Notably, Xywav sales surged 89% to $235 million, while Xyrem sales fell 19% to $269.4 million, marking a shift in patient preference. The company achieved a net leverage ratio of 3.2x, ahead of schedule. Additionally, the FDA cleared JZP815 for clinical development, expanding Jazz's oncology pipeline. Adjusted EPS for the quarter rose to $4.30.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is set to report its 2022 second quarter financial results on August 3, 2022, after U.S. market close. A live audio webcast will occur at 4:30 p.m. ET for a financial update and discussion of results. Interested parties can register in advance through Jazz's website. Jazz Pharmaceuticals is committed to developing life-changing medicines in neuroscience and oncology, with a global presence and innovative therapies.

Jazz Pharmaceuticals announced top-line results from the Phase 3 RELEASE MSS1 trial evaluating nabiximols oromucosal spray (JZP378) for multiple sclerosis spasticity. The trial did not meet its primary endpoint of changing Lower Limb Muscle Tone-6 at Day 21. Despite this setback, Jazz remains committed to the nabiximols program, with plans to present data at a future medical meeting. The ongoing Phase 3 trials, RELEASE MSS3 and RELEASE MSS5, aim to supplement this data. Nabiximols has been approved in 29 countries but is not yet FDA-approved in the U.S.

Jazz Pharmaceuticals announced positive results from a Phase 2/3 trial of Rylaze (asparaginase erwinia chrysanthemi) in treating acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). Conducted in collaboration with the Children's Oncology Group, the trial showed that over 90% of patients achieved clinically meaningful nadir serum asparaginase activity. The findings support a new intramuscular dosing schedule aligned with current clinical practices. Rylaze, approved in 2021 for patients with hypersensitivity to E. coli-derived asparaginase, is set to enhance treatment options.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) will participate in the Jefferies Healthcare Conference on June 8, 2022, at 11:00 a.m. PT / 2:00 p.m. ET / 7:00 p.m. IST in New York. An audio webcast of the presentation will be accessible via the Jazz Pharmaceuticals website, with a replay available for 30 days. Jazz Pharmaceuticals is committed to developing innovative treatments for serious diseases and operates globally, serving nearly 75 countries. For more details, visit their official site or follow @JazzPharma on Twitter.