Jazz Pharmaceuticals, Inc. - JAZZ STOCK NEWS

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.

Jazz Pharmaceuticals (Nasdaq: JAZZ) recently announced the enrollment of the first patient in the IMforte Phase 3 trial, evaluating Zepzelca^® (lurbinectedin) with Tecentriq^® (atezolizumab) for extensive-stage small cell lung cancer (ES-SCLC). This trial aims to assess the combination's efficacy in improving progression-free and overall survival compared to Tecentriq alone. If successful, it could support an FDA application for Zepzelca as a first-line maintenance therapy. This collaboration with Roche addresses a significant medical need, given the aggressive nature of ES-SCLC.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) will participate in two upcoming virtual investor conferences. The first is the Jefferies London Healthcare Conference on November 16, 2021, scheduled for 11:20 – 11:55 a.m. ET. The second is the Evercore ISI HealthCONx Conference on November 30, 2021, from 2:40 – 3:25 p.m. ET. Webcasts of the presentations can be accessed on their website, with replays available for 30 days. Jazz is a biopharmaceutical company based in Dublin, focusing on innovative treatments in neuroscience and oncology.

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) reported a 39% increase in total revenues to $838.1 million for Q3 2021 compared to Q3 2020. Recently launched or acquired products contributed over 50% to net sales. Key highlights include strong adoption of Xywav, resulting in $153.1 million in sales, and a 21% revenue growth for Epidiolex at $160.4 million. The company raised its 2021 earnings guidance and decreased its net leverage ratio to 4.4x. However, GAAP net income showed a loss of $52.8 million per diluted share, contrasting with a profit of $148.2 million in the previous year.