"I am delighted to be stepping into the role of CCO and look forward to leading the combined commercial organization as we continue to scale. I am deeply invested in Jazz's mission and purpose to help patients and remain focused on our commitment to deliver sustainable growth and enhanced value as an innovative global biopharmaceutical company," said Ms. Pearce. "I have had the privilege of leading Jazz's Europe and International organization since 2020 and look forward to continuing to partner closely with ...

Jazz Pharmaceuticals (JAZZ) announced that a mid-stage study evaluating the efficacy and safety of its investigational candidate, suvecaltamide (JZP385), in adult patients with essential tremor (ET) did not meet its primary endpoint. The study also failed to achieve statistical significance on the key secondary endpoint of the Clinical Global Impression-Severity scale, which is a measure of the severity of illness compared with placebo at week 12. Jazz's shares lost 4.7% during trading hours on Jun 20, afte ...

Jazz announced that suvecaltamide failed to meet the primary endpoint in the phase 2b trial, but the company is blaming the placebo response: The oxybate franchise is doing well despite the availability of generic Xyrem and the recent launch of Lumryz Jazz Pharmaceuticals earnings reports Jazz Pharmaceuticals earnings reports deliormanli Suvecaltamide fails in the phase 2b trial in patients with essential tremor While not statistically significant, numeric improvements were observed on the primary endpoint ...

Core Insights - Jazz Pharmaceuticals announced top-line results from the Phase 2b clinical trial evaluating suvecaltamide (JZP385) for essential tremor, which did not achieve statistical significance on the primary endpoint compared to placebo [6][11] - The trial involved 420 participants across four countries and assessed the efficacy and safety of suvecaltamide at doses of 10mg, 20mg, and 30mg [11] - Suvecaltamide was well tolerated, with a safety profile consistent with previous studies, and the most common treatment-emergent adverse events were mild to moderate [7] Phase 2b Trial Details - The trial was a 12-week, multicenter, double-blind, randomized, placebo-controlled study [11] - The primary endpoint was the modified TETRAS composite outcome score, while the key secondary endpoint measured the percentage of participants with a ≥1 point improvement on the CGI-S scale [11] - Numeric improvements were observed at the 30mg dose versus placebo, although not statistically significant [1][6] About Suvecaltamide - Suvecaltamide is a highly selective and state-dependent modulator of T-type calcium channels, which are involved in muscle movement control [3] - The ongoing Phase 2 proof-of-concept trial in Parkinson's disease tremor is expected to provide further insights, with results anticipated in the first quarter of 2025 [11] Company Overview - Jazz Pharmaceuticals is a global biopharmaceutical company focused on developing life-changing medicines for serious diseases with limited therapeutic options [8] - The company has a diverse portfolio, including therapies for sleep disorders, epilepsy, and a growing range of cancer treatments [8]

"We are encouraged by the updated results from the pivotal HERIZON-BTC-01 trial demonstrating sustained clinical activity in previously treated patients with advanced HER2-positive BTC. Results from HERIZON- BTC-01 were included in the Biologics License Application (BLA) for zanidatamab, which was granted Priority Review by the FDA earlier this week, as well as in the Marketing Authorization Application for zanidatamab which was recently submitted to the European Medicines Agency," said Rob Iannone, M.D., M ...

Thirteen abstracts, including five late-breaking abstracts, underscore Jazz's ongoing commitment to advancing the understanding and treatment of serious sleep disorders Oral presentation of XYLO study design to assess systolic blood pressure changes in oxybate patients after switching to low-sodium Xywav® DUBLIN, May 30, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that thirteen abstracts, including five late-breaking abstracts, featuring new data from across its sleep medici ...

DUBLIN, May 29, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that Company management will participate in the following investor conferences: Jefferies Global Healthcare Conference on Thursday, June 6, 2024 Fireside chat at 11:00 a.m. PT / 2:00 p.m. ET / 7:00 p.m. IST Goldman Sachs 45th Annual Global Healthcare Conference on Wednesday, June 12, 2024 Fireside chat at 7:40 a.m. PT / 10:40 a.m. ET / 3:40 p.m. IST Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma compa ...

Core Insights - The FDA has accepted and granted Priority Review for Jazz Pharmaceuticals' zanidatamab, targeting HER2-positive biliary tract cancer, with a PDUFA date set for November 29, 2024 [1][2] - Zanidatamab is positioned to be the first HER2-targeted treatment specifically indicated for patients with HER2+ locally advanced or metastatic biliary tract cancer [1][2] Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for serious diseases, including a growing portfolio of cancer treatments [8] - The company is headquartered in Dublin, Ireland, and is committed to innovative research and development across oncology and neuroscience [8] Clinical Development - The BLA submission for zanidatamab is based on Phase 2b HERIZON-BTC-01 trial results, which showed a confirmed objective response rate of 41.3% in previously treated patients [2][4] - Ongoing Phase 3 HERIZON-BTC-302 trial aims to evaluate zanidatamab's efficacy and safety in combination with standard-of-care therapy for first-line advanced or metastatic HER2-positive biliary tract cancer [3] Regulatory Designations - Zanidatamab has received Breakthrough Therapy designation from the FDA for previously treated HER2 gene-amplified biliary tract cancers, along with two Fast Track designations [5] - The drug has also been granted Orphan Drug designations by both the FDA and the European Medicines Agency for biliary tract cancer and gastric cancer [5] Disease Context - Biliary tract cancer (BTC) accounts for less than 1% of all adult cancers globally and is associated with a poor prognosis, with approximately 12,000 new HER2+ BTC cases diagnosed annually in the U.S., Europe, and Japan [6]

NodThera INC ("NodThera" or the "Company") NodThera Announces Appointment of Daniel Swisher as Chief Executive Officer Dan joins NodThera with over 30 years of pharmaceutical industry leadership experience, including as President and COO of Jazz Pharmaceuticals and CEO of Sunesis Pharmaceuticals Interim CEO Alan Watt becomes President and CSO including leadership of R&D to further build out NodThera's pioneering work in CNS modulation of chronic inflammatory diseases BOSTON, MA, May 28, 2024 - NodThera, a l ...

DUBLIN, May 22, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced a strategic collaboration with Life Science Cares to drive social impact through employee volunteerism in the United States. This partnership reinforces Jazz's commitment to supporting the communities in which employees work and live. Life Science Cares is a collective effort to activate the financial and human capital of the life sciences industry across several regions in the U.S. – and partner with nonprofits – t ...