Jazz Pharmaceuticals (JAZZ) has upcoming FDA regulatory milestones for Ziihera. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Jazz Pharmaceuticals (JAZZ).
Over the past two years, Jazz Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Xywav, Zanidatamab, Ziihera, JZP3507, dordaviprone, Zepzelca, and Epidiolex. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Xywav FDA Regulatory Timeline and Events
Xywav is a drug developed by Jazz Pharmaceuticals for the following indication: Idiopathic hypersomnia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Xywav
- Announced Date:
- June 4, 2026
- Indication:
- Idiopathic hypersomnia
Announcement
Jazz Pharmaceuticals plc announced that the company will present 21 abstracts, including 11 late-breaking abstracts, at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), taking place June 14-17, 2026, in Baltimore.
AI Summary
Jazz Pharmaceuticals said it will present 21 abstracts, including 11 late-breaking abstracts, at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies, in Baltimore from June 14-17, 2026. The company said the research highlights its ongoing focus on treating narcolepsy and idiopathic hypersomnia. Jazz also noted that the presentations will include new findings on its sleep medicine program, with an emphasis on real-world and clinical data. The announcement is meant for U.S. media and investors and points to Jazz’s continued effort to advance care for people with serious sleep disorders. The company said the full list of presentations will be shared for the meeting. This update centers on Jazz’s upcoming scientific presentations and its broader commitment to sleep medicine research.
Read Announcement- Drug:
- Xywav
- Announced Date:
- September 22, 2025
- Indication:
- Idiopathic hypersomnia
Announcement
Jazz Pharmaceuticals plc announced new real-world evidence and Phase 4 data reinforcing the value of Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution treatment outcomes in adults with narcolepsy or idiopathic hypersomnia (IH) were presented at World Sleep 2025, held in Singapore from September 5-10, 2025, as well as the 38th annual Psych Congress, held in San Diego from September 17-21, 2025.
AI Summary
In September 2025, Jazz Pharmaceuticals presented new real-world evidence and Phase 4 DUET trial data on Xywav® (low-sodium oxybate) at World Sleep 2025 in Singapore and the 38th Annual Psych Congress in San Diego. Across 20 abstracts, findings highlighted significant improvements in both daytime and nighttime symptoms for adults with narcolepsy or idiopathic hypersomnia (IH).
The DUET trial, a single-arm, open-label study, showed Xywav reduced awakenings, decreased wake after sleep onset, and improved actigraphy measures in narcolepsy and IH patients. Analyses also demonstrated reduced sleep inertia, fewer psychomotor vigilance lapses, and lower Karolinska Sleepiness Scale ratings upon waking.
Real-world data underscored the cardiovascular and renal risks tied to high sodium intake, emphasizing the benefits of low-sodium Xywav. Additionally, participants taking doses above 9 grams nightly experienced further reductions in sleepiness and cataplexy versus baseline.
These results reinforce Xywav’s value in improving sleep quality, daily functioning, and long-term health outcomes for people living with narcolepsy or IH.
Read Announcement- Drug:
- Xywav
- Announced Date:
- May 29, 2025
- Indication:
- Idiopathic hypersomnia
Announcement
Jazz Pharmaceuticals plc announced that nineteen abstracts, including eleven late-breaking abstracts will be presented at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS) being held June 8-11, 2025, in Seattle.
AI Summary
Jazz Pharmaceuticals plc announced that nineteen abstracts, including eleven late-breaking abstracts, will be presented at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS) in Seattle, from June 8-11, 2025. This collection of studies highlights Jazz’s leadership and commitment in the field of sleep medicine.
The presentations focus on low-sodium oxybate (Xywav®) and its effectiveness in treating narcolepsy and idiopathic hypersomnia. Results from ongoing Phase 4 studies, such as the XYLO, DUET, and LYRICAL trials, will be showcased. These studies include data on blood pressure changes, sleep quality improvements, and overall patient outcomes, underlining the potential benefits of reducing sodium intake in these patients. Jazz’s work at SLEEP 2025 emphasizes its dedication to advancing research and improving care for individuals with challenging sleep disorders.
Read Announcement
Zanidatamab FDA Regulatory Timeline and Events
Zanidatamab is a drug developed by Jazz Pharmaceuticals for the following indication: In HER2+/HR+ Metastatic Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zanidatamab
- Announced Date:
- May 7, 2026
- Indication:
- In HER2+/HR+ Metastatic Breast Cancer
Announcement
ALX Oncology Holdings Inc announced that data from exploratory analyses in the Phase 1b/2 clinical trial evaluating the company's investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' zanidatamab (ZIIHERA®) in patients with heavily pre-treated HER2-positive metastatic breast cancer (mBC) were presented for the first time today in a poster session at the ESMO Breast Cancer 2026 congress.
AI Summary
ALX Oncology reported that exploratory analyses from its Phase 1b/2 trial of evorpacept (a CD47 inhibitor) combined with Jazz Pharmaceuticals’ zanidatamab were presented today in a poster session at the ESMO Breast Cancer 2026 congress. The data come from heavily pre-treated patients with HER2-positive metastatic breast cancer and, according to ALX, further support a biomarker-driven development approach for evorpacept.
The exploratory dataset included 24 patients (10 with centrally confirmed HER2-positive disease). Seventeen of 24 tumor samples were evaluable for CD47 expression, including samples from nine of the 10 centrally confirmed patients. Patients received zanidatamab plus evorpacept at 20 mg/kg (n=3) or 30 mg/kg (n=21). The analyses used an August 1, 2024 data cut-off.
ALX said the findings are consistent with prior ASPEN-06 results in HER2-positive gastric cancer, suggesting CD47 expression may be a predictive biomarker for evorpacept activity. The company will discuss these results in more detail during a May 8 webcast reporting first-quarter 2026 financial results.Read Announcement
- Drug:
- Zanidatamab
- Announced Date:
- April 30, 2026
- Indication:
- In HER2+/HR+ Metastatic Breast Cancer
Announcement
ALX Oncology Holdings Inc announced that new data from the Phase 1b/2 clinical trial evaluating the company's investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' zanidatamab (ZIIHERA®) in heavily pretreated patients with HER2-positive metastatic breast cancer (mBC) will be presented at the ESMO Breast Cancer 2026 Congress in Berlin on May 7.
Read Announcement- Drug:
- Zanidatamab
- Announced Date:
- May 30, 2025
- Indication:
- In HER2+/HR+ Metastatic Breast Cancer
Announcement
Zymeworks Inc announced that the National Medical Products Administration (NMPA) in China has approved zanidatamab for the treatment of patients with previously treated, unresectable or metastatic HER2-positive (HER2+) biliary tract cancer (BTC).
AI Summary
Zymeworks Inc announced that China’s National Medical Products Administration (NMPA) has granted conditional approval for zanidatamab to treat patients with previously treated, unresectable, or metastatic HER2-positive (HER2+) biliary tract cancer (BTC). This approval, based on results from the HERIZON-BTC-01 clinical study, marks zanidatamab as the first and only dual HER2-targeted bispecific antibody approved in China for treating patients with HER2-high expression BTC.
The approval comes under a collaboration with BeOne Medicines, with Zymeworks set to receive a $20 million milestone payment and potential additional payments of up to $144 million as development continues. This step is seen as a significant breakthrough in addressing the high unmet need for effective treatments in patients battling this aggressive form of cancer.
Read Announcement- Drug:
- Zanidatamab
- Announced Date:
- May 22, 2025
- Indication:
- In HER2+/HR+ Metastatic Breast Cancer
Announcement
Zymeworks Inc announced multiple presentations related to its oncology programs at upcoming medical conferences, including the American Society of Clinical Oncology (ASCO) Annual Meeting, and the European Society of Medical Oncology (ESMO) Gynaecological Cancers Congress.
AI Summary
Zymeworks Inc. announced that it will present multiple oncology program updates at upcoming medical conferences. The company’s partners, including Jazz Pharmaceuticals, Johnson & Johnson, and Daiichi Sankyo, will share long-term outcomes and survival data for zanidatamab, a treatment for HER2-positive gastroesophageal cancer, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. This data underscores the potential of Zymeworks’ proprietary Azymetric™ platform to create innovative therapeutic antibodies. Additionally, Zymeworks will feature trial-in-progress posters at ASCO and at the European Society of Medical Oncology (ESMO) Gynaecological Cancers Congress in Vienna, highlighting early clinical developments for novel therapies such as ZW171 and ZW191 in various solid tumors. These presentations reinforce the firm’s commitment to advancing its oncology pipeline and addressing significant unmet medical needs through its cutting-edge research.
Read Announcement- Drug:
- Zanidatamab
- Announced Date:
- April 25, 2025
- Indication:
- In HER2+/HR+ Metastatic Breast Cancer
Announcement
Jazz Pharmaceuticals plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+)† biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.1
AI Summary
Jazz Pharmaceuticals plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for zanidatamab. This investigational dual HER2-targeted bispecific antibody is recommended for conditional marketing authorization as a monotherapy. It is aimed at treating adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC) who have already received at least one prior line of systemic therapy.
This step is seen as an important milestone in the fight against an aggressive and hard-to-treat cancer type. If approved by the European Commission, zanidatamab will become the first HER2-targeted therapy available in the EU for patients with this rare subtype of BTC, addressing a significant unmet medical need.
Read Announcement- Drug:
- Zanidatamab
- Announced Date:
- December 10, 2024
- Indication:
- In HER2+/HR+ Metastatic Breast Cancer
Announcement
ALX Oncology Holdings Inc , announced results from a Phase 1b/2 clinical trial demonstrating the company's investigational CD47-blocker evorpacept in combination with Jazz Pharmaceuticals' zanidatamab generates promising anti-tumor activity in patients with both HER2-positive and HER2-low advanced breast cancer.
AI Summary
ALX Oncology Holdings Inc recently announced promising early results from a Phase 1b/2 clinical trial. The study evaluated the investigational CD47-blocker evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab in patients with advanced breast cancer. The trial included both HER2-positive and HER2-low patients who had already received multiple prior HER2-targeted treatments. Notably, HER2-positive patients showed encouraging responses; one subgroup reported an objective response rate of 55.6% with extended progression-free survival, suggesting that even heavily pretreated patients may benefit from this novel combination. The treatment was generally well tolerated, with most side effects being low-grade, such as fatigue, nausea, and infusion-related reactions. These findings support the potential of evorpacept combined with a HER2-targeted agent as a new therapeutic option for patients who have exhausted standard treatments for advanced breast cancer.
Read Announcement- Drug:
- Zanidatamab
- Announced Date:
- September 16, 2024
- Indication:
- In HER2+/HR+ Metastatic Breast Cancer
Announcement
Jazz Pharmaceuticals plc announced updated data, including median progression-free survival (mPFS) and overall survival (OS) findings, from the Phase 2 trial of zanidatamab, an investigational dual HER2-targeted bispecific antibody, in combination with chemotherapy as first-line treatment for patients with HER2-expressing advanced or metastatic gastroesophageal adenocarcinoma (mGEA).
AI Summary
Jazz Pharmaceuticals recently announced updated Phase 2 trial results for zanidatamab, a dual HER2-targeted bispecific antibody, used with chemotherapy in treating HER2-expressing advanced or metastatic gastroesophageal adenocarcinoma. In this trial involving 41 patients, the confirmed objective response rate reached 84%, with a median duration of response of 18.7 months. Notably, patients experienced a median progression-free survival (mPFS) of 15.2 months, with a 95% confidence interval of 9.5 to 33.4 months. Although overall survival (OS) data remains immature, Kaplan-Meier estimates showed a 65% OS rate at 24 months and 59% at 30 months after a median follow-up of approximately 41.5 months. These promising outcomes support zanidatamab’s potential as an effective first-line therapy for patients with HER2-positive gastroesophageal adenocarcinoma, indicating sustained antitumor activity and a favorable safety profile.
Read Announcement- Drug:
- Zanidatamab
- Announced Date:
- September 9, 2024
- Indication:
- In HER2+/HR+ Metastatic Breast Cancer
Announcement
Jazz Pharmaceuticals plc announced that the Company, along with its partners, will present five abstracts at the European Society for Medical Oncology (ESMO) Congress 2024 from September 13-17, 2024, in Barcelona, Spain. Presentations include data from trials of zanidatamab and Zepzelca® (lurbinectedin).
AI Summary
Jazz Pharmaceuticals announced that the company, along with its partners, will showcase five abstracts at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13-17, 2024. Among these presentations, key data will be shared from clinical trials testing zanidatamab and Zepzelca® (lurbinectedin). The zanidatamab data comes from an ongoing Phase 2 trial studying its use in combination with chemotherapy for first-line treatment of HER2-positive metastatic gastroesophageal adenocarcinoma. Additional data from a trial in HER2-positive metastatic colorectal cancer will also be featured. Moreover, Zepzelca results from a Phase 2 trial in relapsed small cell lung cancer are part of the congress content, emphasizing its efficacy and safety. These presentations underline Jazz Pharmaceuticals’ commitment to advancing new cancer treatment options and providing up-to-date clinical insights to the oncology community.
Read Announcement- Drug:
- Zanidatamab
- Announced Date:
- June 10, 2024
- Indication:
- In HER2+/HR+ Metastatic Breast Cancer
Announcement
Zymeworks Inc announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has accepted the BLA for zanidatamab for second-line treatment of HER2-positive BTC.
AI Summary
Zymeworks Inc announced an important regulatory milestone in China with the acceptance of its Biologics License Application (BLA) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The BLA is for zanidatamab as a second-line treatment for HER2-positive biliary tract cancer (BTC) in patients who have already received treatment. This decision was based on data from the HERIZON-BTC-01 clinical trial, which showed promising anticancer activity and durable responses in patients with advanced, unresectable BTC. As part of its collaboration with BeiGene in Asia Pacific, Zymeworks will receive an $8 million milestone payment upon this acceptance and may receive up to an additional $164 million based on future milestones and product sales royalties. This collaboration highlights the ongoing global efforts to develop targeted therapies for difficult-to-treat cancers and offers hope for improved treatment outcomes in HER2-positive BTC.
Read Announcement
Ziihera FDA Regulatory Timeline and Events
Ziihera is a drug developed by Jazz Pharmaceuticals for the following indication: For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Ziihera
- Announced Date:
- April 27, 2026
- Target Action Date:
- August 25, 2026
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced that The FDA has set a PDUFA target action date of August 25, 2026.
AI Summary
Jazz Pharmaceuticals plc said the U.S. Food and Drug Administration has set a PDUFA target action date of August 25, 2026. This date is when the FDA plans to complete its review and make a decision on the regulatory filing for zanidatamab in the United States.
Zanidatamab is being developed as a targeted treatment for solid tumors that express HER2. Jazz and BeOne are developing the drug under license from Zymeworks, and it is being studied in multiple clinical trials to assess safety and effectiveness in different tumor types.
Important safety issues include the risk of fetal harm if given during pregnancy, infusion-related reactions, and potentially severe diarrhea. Patients should have heart function monitored before and during treatment, and females of reproductive potential should use effective contraception during treatment and for four months after the last dose.Read Announcement
- Drug:
- Ziihera
- Announced Date:
- April 27, 2026
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review the supplemental Biologics License Application (sBLA) for Ziihera® (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA).
AI Summary
Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for filing, with Priority Review, a supplemental Biologics License Application (sBLA) for Ziihera® (zanidatamab-hrii). The filing seeks approval of Ziihera in combination regimens as a first-line treatment for adult patients with HER2-positive, unresectable locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or gastroesophageal adenocarcinoma (GEA).
The Prescription Drug User Fee Act (PDUFA) target action date for the review is August 25, 2026. Zanidatamab is being developed in multiple clinical trials as a targeted treatment for HER2-expressing solid tumors and is being developed by Jazz Pharmaceuticals and BeOne under license from Zymeworks. The Priority Review designation signals an accelerated review timeline by the FDA for this supplemental application addressing first-line therapy in these HER2-positive cancers.
Read Announcement- Drug:
- Ziihera
- Announced Date:
- April 21, 2026
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced that the Company and its partners will present three rapid oral and seven poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 29-June 2, 2026, in Chicago.
AI Summary
Jazz Pharmaceuticals announced that the company and its partners will present three rapid oral and seven poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29–June 2, 2026, in Chicago. The presentations will cover clinical and real‑world findings for therapies aimed at HER2‑expressing solid tumors.
A highlighted rapid oral presentation will report PD‑L1 subgroup data from the HERIZON‑GEA‑01 trial evaluating zanidatamab combinations. Additional Jazz‑supported analyses will address tolerability, biomarker response, and real‑world treatment patterns in HER2‑positive gastroesophageal adenocarcinoma (GEA). Zanidatamab is being developed by Jazz and BeOne under license from Zymeworks and is being studied across multiple trials as a targeted HER2 therapy. These presentations are intended to clarify efficacy in key patient subgroups and inform clinical practice and future research directions.
Read Announcement- Drug:
- Ziihera
- Announced Date:
- March 18, 2026
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals announced that the company and its partners will present one oral and six poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17-22, 2026, in San Diego.
AI Summary
Jazz Pharmaceuticals and its partners will present one oral and six poster presentations at the 2026 American Association for Cancer Research (AACR) Annual Meeting, April 17–22, 2026, in San Diego. The seven presentations will share new insights into zanidatamab’s differentiated HER2 biology, emerging preclinical data on dordaviprone (formerly ONC201) and related imipridones, and advancing research on JZP898, a conditionally activated IFNα2b cytokine.
Highlights include data on zanidatamab across HER2‑expressing solid tumors and exploration of biomarker‑driven trial designs, such as adaptive organ‑preservation strategies in gastroesophageal adenocarcinoma (GEA). The AACR abstracts are available at https://www.aacr.org/meeting/aacr-annual-meeting-2026/ for those who want the full list of Jazz- and partner‑supported presentations. This slate underscores Jazz’s focus on targeted biology and next‑generation approaches in oncology research.
Read Announcement- Drug:
- Ziihera
- Announced Date:
- January 6, 2026
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced positive efficacy and safety results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera® (zanidatamab-hrii) in combination with chemotherapy, with or without the PD-1 inhibitor Tevimbra® (tislelizumab), as first-line treatment for adults with HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA), including cancers of the stomach, gastroesophageal junction and esophagus.
AI Summary
Jazz Pharmaceuticals reported positive Phase 3 HERIZON-GEA-01 results for Ziihera (zanidatamab-hrii) combined with chemotherapy, with or without PD‑1 inhibitor Tevimbra (tislelizumab), as first‑line treatment for adults with HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). Both Ziihera arms reduced the risk of progression or death by about 35% versus trastuzumab plus chemotherapy, raising median progression‑free survival to 12.4 months (vs 8.1 months). The Ziihera + tislelizumab + chemotherapy arm showed a significant overall survival benefit (median OS 26.4 months; 28% lower risk of death), while Ziihera + chemotherapy had median OS 24.4 months with a strong trend toward significance. Benefits were consistent across prespecified subgroups, including PD‑L1 status.
The safety profile was consistent with known HER2‑directed and immunotherapy effects and showed no new signals. Grade ≥3 treatment‑related adverse events occurred in 71.8% (triple), 59.0% (double), and 59.6% (control) arms; severe diarrhea was the most common serious event. These late‑breaking data will be presented at ASCO‑GI on January 8, 2026.
Read Announcement- Drug:
- Ziihera
- Announced Date:
- December 2, 2025
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced two abstracts featuring key data for Ziihera® (zanidatamab-hrii) have been accepted for presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) from January 8-10, 2026, in San Francisco.
AI Summary
Jazz Pharmaceuticals announced two abstracts with key data for Ziihera (zanidatamab-hrii) have been accepted for presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), Jan. 8–10, 2026, in San Francisco. One submission is a late-breaking oral presentation of the Phase 3 HERIZON-GEA-01 trial in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA).
The HERIZON-GEA-01 trial tested Ziihera plus chemotherapy, with or without the PD‑1 inhibitor tislelizumab, against the control arm of trastuzumab plus chemotherapy. Both Ziihera combinations showed highly statistically significant and clinically meaningful improvements in progression-free survival. The triplet with tislelizumab also demonstrated statistically significant and clinically meaningful overall survival benefit, while Ziihera plus chemotherapy showed a clinically meaningful effect with a strong trend toward statistical significance for overall survival at this first analysis.
In addition, a post-hoc overall survival analysis from the HERIZON-BTC-01 Phase 2b trial in previously treated HER2-positive biliary tract cancer will be presented as a poster. Jazz will host an investor webcast on Jan. 9, 2026 to review the presented data.
Read Announcement- Drug:
- Ziihera
- Announced Date:
- July 1, 2025
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced that the European Commission (EC) has granted conditional marketing authorization1 for Ziihera® (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+)† biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy.2
AI Summary
Jazz Pharmaceuticals announced that the European Commission has granted conditional marketing authorization for Ziihera® (zanidatamab) as a monotherapy for adults with unresectable locally advanced or metastatic HER2-positive biliary tract cancer (BTC) after at least one systemic treatment. Ziihera is a dual HER2-targeted bispecific antibody designed to bind to HER2 and reduce cancer cell growth. This approval is based on positive outcomes from the Phase 2b HERIZON-BTC-01 trial, which showed an objective response rate of 41.3% overall—and 51.6% in patients with high HER2 expression (IHC 3+). As the first HER2-targeted therapy conditionally authorized in the European Union for HER2-positive BTC, Ziihera offers a new treatment option for patients with this rare, aggressive cancer who previously had limited options.
Read Announcement- Drug:
- Ziihera
- Announced Date:
- June 2, 2025
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced long-term data, including the first report of median overall survival (OS) from the Phase 2 trial evaluating Ziihera® (zanidatamab-hrii), a dual HER2-targeted bispecific antibody, in combination with chemotherapy for the investigational use in first-line HER2-positive (IHC 3+ or IHC 2+/FISH+) locally advanced nonresectable gastroesophageal adenocarcinoma (mGEA).
AI Summary
Jazz Pharmaceuticals plc announced long-term data from its Phase 2 trial evaluating Ziihera® (zanidatamab‑hrii), a dual HER2-targeted bispecific antibody, combined with chemotherapy. This investigational treatment is being studied for first‑line use in patients with HER2‑positive (IHC 3+ or IHC 2+/FISH+) locally advanced nonresectable gastroesophageal adenocarcinoma (mGEA).
For the first time, the study reported median overall survival (OS) results, offering key insights into the potential benefit of this combination therapy. The findings suggest that using Ziihera with chemotherapy may improve survival outcomes for patients with a challenging cancer type. These long‑term data support further research into whether this novel approach could become an important treatment option in managing HER2‑positive gastroesophageal cancer.
Read Announcement- Drug:
- Ziihera
- Announced Date:
- December 5, 2024
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced that zanidatamab-hrii (Ziihera®) 50 mg/mL for injection for intravenous use is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A treatment option for Biliary Tract Cancers (BTC).
AI Summary
Jazz Pharmaceuticals plc announced that its drug zanidatamab-hrii (Ziihera®) 50 mg/mL for injection has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology as a category 2A treatment option for biliary tract cancers (BTC). This inclusion highlights the drug’s growing importance as a treatment option for patients with HER2-positive (IHC 3+) BTC, a disease known for its limited treatment choices and poor prognosis. The NCCN Guidelines, widely used by physicians, nurses, pharmacists, and other healthcare professionals, provide expert recommendations for cancer therapy and play a key role in treatment decision-making.
According to Jazz Pharmaceuticals, the addition of Ziihera to these guidelines reinforces the commitment to offer innovative, chemotherapy-free therapeutic options for patients with BTC. This step is seen as a significant milestone in expanding access to targeted treatments for individuals battling this challenging form of cancer.
Read Announcement- Drug:
- Ziihera
- Announced Date:
- December 4, 2024
- Target Action Date:
- December 11, 2024
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced that it will host a webcast on Wednesday, December 11, 2024, at 4:30 p.m. ET / 9:30 p.m. GMT to provide an overview of clinical data, patient need and commercialization strategy for Ziihera® (zanidatamab-hrii), the first chemotherapy-free dual HER2-targeted bispecific antibody indicated for biliary tract cancer (BTC).
AI Summary
Jazz Pharmaceuticals plc announced that it will host a webcast on Wednesday, December 11, 2024, at 4:30 p.m. ET / 9:30 p.m. GMT. The webcast will provide an overview of key clinical data, the unmet patient need, and the commercialization strategy for Ziihera® (zanidatamab-hrii). Ziihera is the first chemotherapy-free, dual HER2-targeted bispecific antibody approved by the FDA for treating adults with unresectable or metastatic HER2-positive biliary tract cancer (BTC).
During the webcast, senior management will discuss how the clinical results from the HERIZON-BTC-01 trial support its use and highlight plans for its market launch. Interested viewers can join the live audio webcast and review additional details by visiting the Jazz Pharmaceuticals Investors website.
Read Announcement- Drug:
- Ziihera
- Announced Date:
- November 20, 2024
- Indication:
- For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Announcement
Jazz Pharmaceuticals plc announced the U.S. Food and Drug Administration (FDA) accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.1 Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by independent central review (ICR).
AI Summary
Jazz Pharmaceuticals announced that the U.S. FDA has granted accelerated approval for Ziihera® (zanidatamab-hrii) 50mg/mL for injection by IV for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC). The treatment is for patients whose cancer tests show HER2 positivity (IHC 3+) using an FDA-approved diagnostic test.
The approval was based on data from the HERIZON-BTC-01 trial, which showed a 52% objective response rate and a median duration of response of 14.9 months, as determined by independent central review. This makes Ziihera the first and only dual HER2-targeted bispecific antibody available for this specific type of cancer. Continued approval might depend on further confirmation of clinical benefits in upcoming trials.
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JZP3507 FDA Regulatory Events
JZP3507 is a drug developed by Jazz Pharmaceuticals for the following indication: In CNS Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- JZP3507
- Announced Date:
- November 11, 2025
- Indication:
- In CNS Tumors
Announcement
Jazz Pharmaceuticals plc announced new preclinical data featuring JZP3507 (formerly ONC206) in central nervous system (CNS) tumors, reflecting Jazz's growing impact and innovation in neuro-oncology.
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Dordaviprone FDA Regulatory Timeline and Events
Dordaviprone is a drug developed by Jazz Pharmaceuticals for the following indication: treatment for recurrent H3 K27M-mutant diffuse glioma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- dordaviprone
- Announced Date:
- November 11, 2025
- Indication:
- treatment for recurrent H3 K27M-mutant diffuse glioma
Announcement
Jazz Pharmaceuticals plc announced that the company will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting taking place November 19-23 in Honolulu, Hawaii.
Read Announcement- Drug:
- dordaviprone
- Announced Date:
- September 9, 2025
- Indication:
- treatment for recurrent H3 K27M-mutant diffuse glioma
Announcement
Jazz Pharmaceuticals plc announced that Modeyso™ (dordaviprone) is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A single-agent treatment option for pediatric and adult patients with recurrent or progressive diffuse high-grade glioma harboring an H3 K27M mutation.
AI Summary
Jazz Pharmaceuticals plc today announced that Modeyso™ (dordaviprone) has been added to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology as a category 2A single-agent treatment option. The recommendation covers both pediatric and adult patients whose diffuse high-grade glioma has returned or worsened and carries the H3 K27M mutation.
This guideline update marks the first time a targeted therapy is endorsed for these patients, reflecting an urgent need for new options against this aggressive brain tumor. The NCCN Guidelines are widely used by doctors, nurses, pharmacists and payers to guide cancer care and help improve patient outcomes. Modeyso is now commercially available in the United States for those with recurrent or progressive H3 K27M-mutant diffuse high-grade glioma, offering hope to patients and families facing limited treatment choices.
Read Announcement- Drug:
- dordaviprone
- Announced Date:
- August 6, 2025
- Indication:
- treatment for recurrent H3 K27M-mutant diffuse glioma
Announcement
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
AI Summary
Jazz Pharmaceuticals announced the FDA has granted accelerated approval to Modeyso (dordaviprone) for adults and children (1 year and older) with diffuse midline glioma carrying an H3 K27M mutation after prior therapy fails. This is the first FDA-approved therapy for this rare, aggressive brain tumor that affects about 2,000 people annually, many of them children and young adults.
Modeyso is taken once weekly as an oral capsule. The approval is based on an integrated analysis of 50 patients from five studies, showing an overall response rate of 22%, with some patients responding for over 10 months. Seventy-three percent of responders maintained benefit for at least six months.
Continued approval depends on confirming clinical benefit in the Phase 3 ACTION trial. Modeyso is expected to be available commercially in the coming weeks, addressing a critical unmet need in neuro-oncology.
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Zepzelca (lurbinectedin) FDA Regulatory Timeline and Events
Zepzelca (lurbinectedin) is a drug developed by Jazz Pharmaceuticals for the following indication: Relapsed Small Cell Lung Cancer (SCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zepzelca (lurbinectedin)
- Announced Date:
- October 2, 2025
- Indication:
- Relapsed Small Cell Lung Cancer (SCLC)
Announcement
Jazz Pharmaceuticals announced that the Food and Drug Administration approved lurbinectedin
Read Announcement- Drug:
- Zepzelca (lurbinectedin)
- Announced Date:
- June 10, 2025
- Target Action Date:
- October 7, 2025
- Indication:
- Relapsed Small Cell Lung Cancer (SCLC)
Announcement
Jazz Pharmaceuticals plc announced that Prescription Drug User Fee Act (PDUFA) action date of October 7, 2025. Priority Review is granted to applications for drugs that have the potential to significantly improve the treatment, prevention, or diagnosis of serious conditions.
AI Summary
Jazz Pharmaceuticals plc announced that the FDA has accepted its supplemental New Drug Application for the cancer drug Zepzelca (lurbinectedin) used with atezolizumab as a first-line maintenance treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). The application is supported by data from the Phase 3 IMforte trial, which showed statistically significant and clinically meaningful improvements in both progression-free and overall survival compared to treatment with atezolizumab alone. The FDA granted Priority Review to this application, a designation reserved for drugs that have the potential to significantly improve the treatment, prevention, or diagnosis of serious conditions. The Prescription Drug User Fee Act (PDUFA) action date is set for October 7, 2025, highlighting the agency’s commitment to expediting the review process for a promising new treatment option for ES-SCLC patients.
Read Announcement- Drug:
- Zepzelca (lurbinectedin)
- Announced Date:
- June 10, 2025
- Indication:
- Relapsed Small Cell Lung Cancer (SCLC)
Announcement
Jazz Pharmaceuticals plc announced the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin, and etoposide for Priority Review
AI Summary
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Zepzelca® (lurbinectedin) combined with atezolizumab (Tecentriq®). This sNDA is being reviewed as a first-line maintenance treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease did not worsen after receiving first-line induction therapy with atezolizumab, carboplatin, and etoposide. The FDA’s decision to grant Priority Review highlights the therapy’s potential to significantly improve treatment outcomes for ES-SCLC patients, a group with limited options and high unmet needs. The acceptance of this application, based on promising data from the Phase 3 IMforte trial, positions the combination therapy as a hopeful new option to delay disease progression and possibly extend survival for patients affected by this aggressive form of lung cancer.
Read Announcement- Drug:
- Zepzelca (lurbinectedin)
- Announced Date:
- April 23, 2025
- Indication:
- Relapsed Small Cell Lung Cancer (SCLC)
Announcement
Jazz Pharmaceuticals plc announced that the company, along with its partners, will present seven abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 30-June 3, 2025, in Chicago and online.
AI Summary
Jazz Pharmaceuticals plc announced that it, along with its partners, will present seven abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting from May 30 to June 3, 2025, in Chicago and online. One highlight is an oral abstract from the Phase 3 IMforte trial, which showed statistically significant improvements in progression-free and overall survival when Zepzelca (lurbinectedin) was combined with Tecentriq (atezolizumab) as a first‐line maintenance treatment for patients with extensive-stage small cell lung cancer.
Other abstracts will cover data from studies on Ziihera in HER2-positive gastroesophageal cancer and investigational dordaviprone in recurrent H3 K27M-mutant diffuse glioma patients. These presentations underscore Jazz Pharmaceuticals’ commitment to advancing targeted treatment options and shaping future cancer care.
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Epidiolex (cannabidiol) FDA Regulatory Timeline and Events
Epidiolex (cannabidiol) is a drug developed by Jazz Pharmaceuticals for the following indication: Epilepsy with Myoclonic-Atonic Seizures (EMAS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Epidiolex (cannabidiol)
- Announced Date:
- December 6, 2024
- Indication:
- Epilepsy with Myoclonic-Atonic Seizures (EMAS)
Announcement
Jazz Pharmaceuticals plc announced nine company-sponsored Epidiolex® (cannabidiol) posters are being presented at the American Epilepsy Society (AES) 2024 Annual Meeting, being held December 6-10 in Los Angeles, California.
AI Summary
Jazz Pharmaceuticals plc announced that nine company-sponsored Epidiolex® (cannabidiol) posters will be presented at the American Epilepsy Society (AES) 2024 Annual Meeting in Los Angeles from December 6-10, 2024. These presentations include new insights into Epidiolex’s benefits for patients with rare epilepsies, with a special focus on data from the EpiCom trial—the first prospective study evaluating the impact of adjunctive Epidiolex on tuberous sclerosis complex (TSC)-associated neuropsychiatric disorders. The EpiCom data revealed improvements in the severity of behavioral symptoms following treatment initiation. Additionally, real-world outcomes from the BECOME surveys (BECOME-TSC and BECOME-LTC) highlight both seizure and non-seizure improvements, as reported by caregivers and nurses, affirming the broad benefits of Epidiolex. These findings are anticipated to enhance the understanding of Epidiolex’s impact beyond seizure control, addressing significant unmet needs in epilepsy treatment.
Read Announcement- Drug:
- Epidiolex (cannabidiol)
- Announced Date:
- September 5, 2024
- Indication:
- Epilepsy with Myoclonic-Atonic Seizures (EMAS)
Announcement
Jazz Pharmaceuticals plc announced that the Company will present eight abstracts at the 15th European Epilepsy Congress (EEC), including a subgroup analysis of the BECOME (BEhavior, COgnition and More with Epidyolex®) Caregiver Survey, a survey of caregivers of patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) reporting outcomes in patients receiving Epidiolex/Epidyolex (cannabidiol, 100mg/mL oral solution) and concomitant clobazam.
AI Summary
Jazz Pharmaceuticals plc announced it will present eight abstracts at the 15th European Epilepsy Congress (EEC). One key presentation is a subgroup analysis of the BECOME Caregiver Survey. This survey gathered real-world insights from caregivers of patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) who were treated with Epidiolex/Epidyolex (a 100mg/mL cannabidiol oral solution) combined with clobazam. The findings demonstrate that most caregivers reported improvements in both seizure-related outcomes and non-seizure measures such as alertness, cognition, and language. These results underline Epidyolex’s potential for enhancing the overall well-being of patients beyond just seizure control. Additional analyses from pivotal trials further support the clinical benefits associated with reduced drop seizures, reinforcing the holistic impact of Epidyolex for patients and their families.
Read Announcement- Drug:
- Epidiolex (cannabidiol)
- Announced Date:
- August 22, 2024
- Indication:
- Epilepsy with Myoclonic-Atonic Seizures (EMAS)
Announcement
Jazz Pharmaceuticals plc announced top-line results from the Phase 3 open-label, single-arm trial in Japan evaluating the safety and efficacy of cannabidiol oral solution (marketed as Epidiolex®/Epidyolex® globally) as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC).
AI Summary
Jazz Pharmaceuticals announced top-line results from its Phase 3, open-label, single-arm trial in Japan, which evaluated the safety and efficacy of its cannabidiol oral solution (marketed as Epidiolex®/Epidyolex®) as an add-on treatment for seizures linked to Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex in pediatric patients. Although the trial did not meet its primary efficacy endpoint of a pre-specified change in seizure frequency over a 16-week period compared to baseline, the study did observe numeric improvements in both the primary and several secondary endpoints.
No new safety issues were identified during the trial. Building on Epidyolex’s established clinical profile from five global Phase 3 studies involving over 900 patients, Jazz Pharmaceuticals plans to continue collecting data in Japan and to consult with regulatory authorities about a potential new drug application, addressing the significant unmet needs in pediatric rare epilepsies.
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Suvecaltamide FDA Regulatory Events
Suvecaltamide is a drug developed by Jazz Pharmaceuticals for the following indication: For the potential treatment of moderate to severe essential tremor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Suvecaltamide
- Announced Date:
- June 20, 2024
- Indication:
- For the potential treatment of moderate to severe essential tremor
Announcement
Jazz Pharmaceuticals plc announced top-line results from the Phase 2b clinical trial (NCT05122650) evaluating the efficacy and safety of suvecaltamide (JZP385), an investigational, highly selective and state-dependent modulator of T-type calcium channels, in adult patients with essential tremor (ET).
AI Summary
Jazz Pharmaceuticals plc recently announced top-line results from its Phase 2b clinical trial (NCT05122650) studying the safety and efficacy of suvecaltamide (JZP385) in adult patients with essential tremor. Suvecaltamide, a highly selective and state-dependent modulator of T-type calcium channels, was evaluated in a once-daily oral dosing regimen. Although the trial did not achieve statistical significance at the 30mg dose compared to placebo for the primary endpoint—change on the Essential Tremor Rating Assessment Scale (TETRAS) modified composite score—or the key secondary endpoint, the Clinical Global Impression-Severity (CGI-S) scale, there were numerical improvements observed in these measures.
The study also showed a favorable safety profile for suvecaltamide, with mostly mild to moderate adverse events including dizziness, headache, paresthesia, diarrhea, and insomnia. Jazz Pharmaceuticals is now reviewing the data and looks ahead to further studies, including a Phase 2 trial in Parkinson’s disease tremor.
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