Jazz Pharmaceuticals Plc Stock Price, News & Analysis

Jazz Pharmaceuticals (Nasdaq: JAZZ) announced positive top-line Phase 3 HERIZON-GEA-01 results on Nov 17, 2025 for Ziihera (zanidatamab-hrii) in first-line HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma.

Both Ziihera+chemotherapy and Ziihera+tislelizumab+chemotherapy showed statistically significant PFS improvements versus trastuzumab+chemotherapy; the triplet also showed statistically significant OS benefit, while the doublet showed a clinically meaningful OS effect with a strong trend toward significance at first interim analysis. Jazz plans a U.S. sBLA submission in 1H 2026 and will seek guideline adoption and medical meeting presentation in early 2026.

Jazz Pharmaceuticals (Nasdaq: JAZZ) will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting, November 19–23 in Honolulu.

Presentations highlight clinical and preclinical data for Modeyso (dordaviprone) in H3 K27M-mutant diffuse midline glioma, translational work on molecular pathways and combination strategies, immune‑modulatory effects, and new preclinical results for JZP3507 (ONC206) in CNS tumors.

Key sessions include oral and poster presentations on Nov 21–23 with multiple pediatric and rare tumor abstracts.

Jazz Pharmaceuticals (Nasdaq: JAZZ) reported 3Q25 total revenues of $1.126B, up 7% year‑over‑year, driven by Xywav, Epidiolex and the Modeyso launch. Modeyso received FDA accelerated approval and generated $11.0M in 3Q25 after an August launch. Xywav sales were $431.4M (+11%) and Epidiolex was $302.6M (+20%). GAAP net income for 3Q25 was $251.4M and non‑GAAP adjusted net income was $500.7M. Cash and investments were $2.0B with long‑term debt of $5.4B. Company narrowed 2025 revenue guidance to $4,175–$4,275M and provided updated GAAP and non‑GAAP guidance.

Jazz Pharmaceuticals (Nasdaq: JAZZ) announced that Ted W. Love, M.D. will join the Board of Directors effective December 1, 2025. Dr. Love brings 30+ years of drug development and global commercialization experience, including leadership roles at Global Blood Therapeutics (CEO until its 2023 acquisition by Pfizer), Onyx, Nuvelo, and Genentech.

The appointment supports Jazz's stated board renewal effort—six directors have been appointed in the past five years—and coincides with the planned retirement of long-tenured director Kenneth O'Keefe, effective December 1, 2025.

Jazz Pharmaceuticals (Nasdaq: JAZZ) will report its 2025 third quarter financial results on Wednesday, November 5, 2025 after the U.S. market close. Management will host a live audio webcast at 4:30 p.m. EST / 9:30 p.m. GMT to discuss the results and provide a business and financial update.

Participants may register in advance via the Investors section of the Jazz Pharmaceuticals website and are recommended to register at least 15 minutes before the webcast. A replay will be available in the Investors events and presentations area.

Jazz Pharmaceuticals is a global biopharma company focused on therapies for sleep disorders, epilepsy, and oncology, headquartered in Dublin with global R&D and manufacturing operations.

Jazz Pharmaceuticals (Nasdaq: JAZZ) announced FDA approval on Oct 2, 2025 of Zepzelca (lurbinectedin) plus atezolizumab (or atezolizumab/hyaluronidase-tqjs) as the first-line maintenance therapy for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after induction with atezolizumab, carboplatin and etoposide.

The approval is based on Phase 3 IMforte results showing a 46% reduction in risk of progression or death and a 27% reduction in risk of death; median OS 13.2 vs 10.6 months (HR=0.73; p=0.0174) and median PFS 5.4 vs 2.1 months (HR=0.54; p<0.0001). The regimen was added to NCCN SCLC guidelines as a preferred maintenance option. Common adverse reactions (≥30%) include cytopenias, nausea, and fatigue.

Jazz Pharmaceuticals (NASDAQ: JAZZ) presented significant Phase 4 data and real-world evidence for Xywav® at World Sleep 2025 and Psych Congress 2025. The key findings from the DUET trial demonstrated positive treatment effects of low-sodium Xywav on both daytime and nighttime symptoms in adults with narcolepsy or idiopathic hypersomnia (IH).

Notable results include improved sleep measures with fewer awakenings in narcolepsy patients, reduced sleep inertia in IH patients, and positive outcomes for patients taking 9-12 gram doses. Real-world analysis revealed that individuals with narcolepsy or IH have an elevated risk of cardiovascular, cardiometabolic and renal complications, emphasizing the importance of low-sodium treatment options.

Jazz Pharmaceuticals (NASDAQ: JAZZ) announced that Modeyso™ (dordaviprone) has been included in the NCCN Clinical Practice Guidelines as a category 2A treatment option for H3 K27M-mutant diffuse glioma. This follows the FDA's accelerated approval on August 6, 2025 for treating adult and pediatric patients with diffuse midline glioma.

Clinical trials demonstrated an overall response rate of 22% among 50 patients, with a median response duration of 10.3 months. Among responders, 73% maintained response for at least six months. Safety evaluation in 376 patients showed serious adverse reactions in 33% of cases, with common side effects including fatigue, headache, and vomiting.

Modeyso represents the first treatment option for this ultra-rare and aggressive brain tumor, marking a significant advancement in patient care.

Jazz Pharmaceuticals (NASDAQ:JAZZ) announced its participation in the upcoming 2025 Wells Fargo Healthcare Conference. Company management will conduct a fireside chat on September 3, 2025, at 6:30 a.m. PDT.

The presentation will be accessible through a live audio webcast on the company's investor relations website, with replays available for 30 days. Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for sleep disorders, epilepsy, and cancer treatments.