Jazz Pharmaceuticals (JAZZ) Company Report

Jazz Pharmaceuticals will present positive Phase 3 HERIZON-GEA-01 trial results for Ziihera in first-line HER2-positive gastroesophageal adenocarcinoma (GEA) at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) from January 8-10, 2026.
The trial demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) for Ziihera combinations compared to the control arm.
An investor webcast will be hosted on Friday, January 9, 2026, at 6:30 a.m. PT/ 9:30 a.m. ET to review the Ziihera data presented at the meeting.

2 days ago

Press Release

Jazz Pharmaceuticals Reports Record Q3 2025 Revenues and Provides Business Updates

JAZZ

Guidance Update

Product Launch

M&A

Jazz Pharmaceuticals reported record revenues of $1.13 billion in Q3 2025, an increase of approximately 7%, and subsequently raised its ANI and EPS guidance. The company also recognized a $206 million deferred tax asset related to the Chimerix acquisition and finished the quarter with $2 billion in cash and investments.
Key products Epidiolex and Xywav demonstrated strong growth, with Epidiolex on track to achieve blockbuster status. Xywav's growth was primarily driven by the idiopathic hypersomnia (IH) indication, with approximately 325 new patient additions in IH in the most recent quarter.
Midaso, acquired through Chimerix, had a strong initial launch, generating $11 million in net sales in Q3 2025 after only a few weeks on the market, serving about 200 patients, and is projected to reach peak sales exceeding $500 million.
The company announced positive data for zanidatamab in the first-line GEA trial, showing statistically significant and clinically meaningful progression-free survival, and received approval for Zepzelca's first-line maintenance indication. Jazz Pharmaceuticals plans to continue external investments in corporate development, focusing on oncology and epilepsy.

3 days ago

Transcript

Jazz Pharmaceuticals Discusses Strong Q3 2025 Performance and Product Pipeline

JAZZ

Guidance Update

Product Launch

New Projects/Investments

Jazz Pharmaceuticals reported record revenues of $1.13 billion in Q3 2025, an increase of approximately 7%, and recognized a $206 million deferred tax asset related to the Chimerix acquisition, leading to updated ANI and EPS guidance.
The company announced strong data from the first-line GEA trial for zanidatamab, showing statistically significant and clinically meaningful progression-free survival for the doublet and both PFS and overall survival for the triplet.
The initial launch of Midaso (from the Chimerix acquisition) generated $11 million in net sales in Q3 2025 from approximately 200 patients in just a few weeks, exceeding expectations and with peak sales potential north of $500 million.
Epidiolex is on track to achieve blockbuster status, while Xywav continues strong growth, primarily from the idiopathic hypersomnia (IH) indication, though generic versions of Xyrem are anticipated in 2026 which could create headwinds. Jazz finished Q3 2025 with about $2 billion in cash and investments.

3 days ago

Transcript

Jazz Pharmaceuticals Discusses Strong Q3 2025 Performance and Strategic Growth Initiatives

JAZZ

Guidance Update

Product Launch

New Projects/Investments

Jazz Pharmaceuticals reported record revenues of $1.13 billion in Q3 2025, an increase of 7%, driven by strong performance from Epidiolex and Xywav. This led to narrowed revenue guidance and increased ANI and EPS guidance.
The company recognized a $206 million deferred tax asset related to the Chimerix acquisition and highlighted the strong initial launch of Modeso, which generated $11 million in net sales in 3Q 2025 from approximately 200 patients.
Jazz announced strong results from the first-line GEA trial for zanidatamab, demonstrating statistically significant and clinically meaningful progression-free survival, with a strong trend towards overall survival benefit.
Xywav continues to grow, primarily from idiopathic hypersomnia (IH), and Epidiolex is on track to achieve blockbuster status. The company ended Q3 2025 with approximately $2 billion in cash and investments.

3 days ago

Transcript

Jazz Pharmaceuticals Reports Positive Phase 3 Results for Ziihera in HER2-Positive GEA

JAZZ

Product Launch

New Projects/Investments

Jazz Pharmaceuticals announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera (zanidatamab-hrii) as a first-line treatment for HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA).
Both Ziihera plus chemotherapy, and Ziihera plus the PD-1 inhibitor Tevimbra (tislelizumab) and chemotherapy, demonstrated highly statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to the control arm.
Ziihera plus tislelizumab and chemotherapy also showed clinically meaningful and statistically significant improvements in overall survival (OS), with Ziihera plus chemotherapy demonstrating a strong trend toward statistical significance for OS at the first interim analysis.
The company plans to submit a supplemental Biologics License Application (sBLA) in the U.S. in the first half of 2026 for Ziihera in this indication.

Nov 17, 2025, 11:28 AM

8-K

Jazz Pharmaceuticals and Zymeworks Report Positive Phase 3 Trial Results for Ziihera

JAZZ

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Zymeworks and Jazz Pharmaceuticals announced positive Phase 3 trial results for their HER2-targeted bispecific antibody Ziihera (zanidatamab-hrii) as a first-line treatment for HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. The HERIZON-GEA-01 trial demonstrated statistically significant improvements in progression-free survival for both treatment regimens, with one combination also showing significant overall survival benefits.
Following the announcement, Zymeworks' stock rose 59% and Jazz Pharmaceuticals' stock gained 31% in premarket trading.
Jazz Pharmaceuticals plans to submit a supplemental Biologics License Application in the first half of 2026 to support Ziihera’s use as a first-line treatment, with an additional overall survival interim analysis expected in mid-2026.
Ziihera is already approved in the U.S., Europe, and China for second-line biliary tract cancer.

Nov 17, 2025, 11:21 AM

Morningstar

Jazz Pharmaceuticals Announces Positive Phase 3 Results for Ziihera in HER2-Positive GEA

JAZZ

Product Launch

New Projects/Investments

Jazz Pharmaceuticals announced positive top-line results from the Phase 3 HERIZON-GEA-01 trial evaluating Ziihera (zanidatamab-hrii) as a first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA).
Both Ziihera plus chemotherapy and Ziihera plus tislelizumab and chemotherapy demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) compared to the control arm.
The combination of Ziihera, tislelizumab, and chemotherapy also showed statistically significant and clinically meaningful improvements in overall survival (OS), while Ziihera plus chemotherapy demonstrated a strong trend toward statistical significance for OS.
The company plans to submit a supplemental Biologics License Application (sBLA) in the U.S. in the first half of 2026, aiming for Ziihera to become the new standard of care for this indication.

Nov 17, 2025, 11:00 AM

Press Release

Jazz Pharmaceuticals to Present New Clinical and Translational Data for Modeyso and JZP3507 at SNO 2025

JAZZ

Product Launch

New Projects/Investments

Jazz Pharmaceuticals will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting from November 19-23 in Honolulu, Hawaii.
The presentations will feature clinical and preclinical research on Modeyso™ (dordaviprone) and new preclinical data for JZP3507 (formerly ONC206), reflecting the company's growing impact and innovation in neuro-oncology.
Modeyso (dordaviprone) received accelerated approval in August 2025 from the U.S. Food and Drug Administration (FDA) for the treatment of H3 K27M-mutant diffuse midline glioma in adult and pediatric patients one year of age and older with progressive disease following prior therapy.
The research aims to provide new insights into optimizing treatment for brain cancer, including characterizing potential molecular pathways associated with dordaviprone sensitivity and exploring its influence on the tumor immune environment.

Nov 11, 2025, 12:45 PM

Press Release

Iambic Raises Over $100 Million in Oversubscribed Financing Round

JAZZ

New Projects/Investments

Iambic, a clinical-stage life science and technology company, has successfully raised over $100 million in an oversubscribed financing round with support from new and existing investors.
The company leverages an AI-driven discovery and development platform to develop novel medicines.
This financing closely follows the presentation of clinical data for IAM1363 at the ESMO Congress and the announcement of a clinical collaboration with Jazz Pharmaceuticals.
Iambic anticipates its KIF18A and CDK2/4 programs entering the clinic in the near term.

Nov 10, 2025, 1:00 PM

Press Release

Jazz Pharmaceuticals Reports Record Q3 2025 Revenue and Narrows Full-Year Guidance

JAZZ

Earnings

Guidance Update

Product Launch

Jazz Pharmaceuticals reported record Q3 2025 total revenues of $1.126 billion, a 7% increase compared to the third quarter of 2024, driven by strong growth from Xywav (up 11% to $431 million) and Epidiolex (up 20% to $303 million).
The company narrowed its full-year 2025 revenue guidance to a range of $4.175-$4.275 billion.
Significant regulatory milestones included FDA approvals for Modeso for recurrent H3K27M-mutant diffuse midline glioma and for Zepzelca in combination with Tecentriq as a first-line maintenance therapy for extensive-stage small cell lung cancer.
Jazz anticipates top-line results from the phase III Zanidatamab Horizon trial in gastroesophageal adenocarcinoma later this quarter, with the PFS analysis now including 920 patients.
The company also reached settlement agreements for the Xyrem antitrust litigation and litigation with Abidel.

Nov 5, 2025, 9:30 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for Jazz Pharmaceuticals.

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