Jazz Pharmaceuticals Plc Stock Price, News & Analysis

Jazz Pharmaceuticals (Nasdaq: JAZZ) has received conditional marketing authorization from the European Commission for Ziihera® (zanidatamab) for treating adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC) who have received at least one prior line of systemic therapy.

The approval is based on the Phase 2b HERIZON-BTC-01 trial results, which demonstrated significant efficacy in the largest study conducted to date in this population. Key findings include:

• Confirmed objective response rate (cORR) of 41.3% in the overall population
• Higher cORR of 51.6% in IHC 3+ tumor patients
• Median duration of response of 14.9 months
• Median overall survival of 18.1 months in IHC 3+ patients

Ziihera becomes the first HER2-targeted therapy authorized for HER2-positive BTC in the European Union. The approval extends to all EU Member States, Iceland, Norway, and Liechtenstein. Continued approval is contingent upon verification of clinical benefit in the ongoing Phase 3 HERIZON-BTC-302 trial.

Jazz Pharmaceuticals announced FDA Priority Review acceptance for Zepzelca in combination with atezolizumab as first-line maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC). The FDA set a PDUFA date of October 7, 2025. The application is supported by Phase 3 IMforte trial results, which showed significant improvements in both progression-free survival (5.4 vs 2.1 months) and overall survival (13.2 vs 10.6 months) compared to atezolizumab alone. The combination reduced disease progression/death risk by 46% and death risk by 27%. The treatment showed no new safety concerns and could provide a crucial new option for ES-SCLC patients, addressing a significant unmet medical need.

Jazz Pharmaceuticals (JAZZ) presented Phase 4 data for Xywav at SLEEP 2025, showcasing positive outcomes in narcolepsy treatment. The XYLO switch study demonstrated significant blood pressure reductions when patients switched from high-sodium to low-sodium oxybate, with a -4.1 mmHg change in 24-hour systolic blood pressure (P=0.0019). The study met its primary endpoint and key secondary endpoints, including improvements in daytime and resting blood pressure. Additionally, the DUET trial analysis showed effectiveness of Xywav at 9-12g doses, higher than the currently recommended 6-9g, with improvements in excessive daytime sleepiness. Both studies reported only mild to moderate treatment-emergent adverse events, consistent with Xywav's known safety profile. Xywav remains the only FDA-approved low-sodium oxybate for treating narcolepsy and idiopathic hypersomnia.

Jazz Pharmaceuticals announced breakthrough results from their Phase 3 IMforte study, showing Zepzelca (lurbinectedin) combined with atezolizumab significantly improved survival in extensive-stage small cell lung cancer (ES-SCLC) patients. The combination therapy, used as first-line maintenance treatment, reduced disease progression or death risk by 46% and demonstrated median overall survival of 13.2 months versus 10.6 months for atezolizumab alone. The study met both primary endpoints with statistically significant improvements in progression-free survival (5.4 vs 2.1 months) and overall survival. The combination therapy showed a manageable safety profile with no new safety signals, though it had higher treatment-related adverse events (83.5% vs 40.0%). This groundbreaking study is the first Phase 3 trial to show meaningful improvements in both progression-free and overall survival in ES-SCLC first-line maintenance, potentially establishing a new standard of care for patients.

Jazz Pharmaceuticals (NASDAQ: JAZZ) reported significant long-term data for Ziihera (zanidatamab-hrii) in treating HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA). The Phase 2 trial showed remarkable results with a median overall survival of 36.5 months and progression-free survival of 15.2 months in centrally confirmed HER2-positive patients. The study demonstrated an impressive 83.8% confirmed objective response rate with a median duration of response of 20.4 months. The treatment showed a manageable safety profile, with diarrhea (39%) and hypokalemia (22%) as the most common Grade 3-4 treatment-related adverse events. These results significantly outperform current standard care treatments, which typically show median survival of 15-20 months. The company expects top-line results from their pivotal Phase 3 HERIZON-GEA-01 trial in late 2025.

Jazz Pharmaceuticals (NASDAQ: JAZZ) will present nineteen abstracts, including eleven late-breaking abstracts, at SLEEP 2025 (June 8-11, Seattle), demonstrating comprehensive research on Xywav® treatment benefits. Key highlights include: • First interim results from the XYLO trial evaluating blood pressure changes in narcolepsy patients switching from high-sodium to low-sodium oxybate • Novel results from DUET trial assessing Xywav's effectiveness on multiple sleep parameters • Data on Xywav effectiveness and safety in narcolepsy patients with doses exceeding 9 grams • Results from CHIME study on real-world outcomes • Findings from INTREPID study on treatment patterns • LYRICAL study interim results showing symptom improvements and patient satisfaction The research emphasizes Jazz's commitment to advancing treatment for narcolepsy and idiopathic hypersomnia while focusing on patient-centric care and addressing cardiovascular risks through low-sodium formulation.

Jazz Pharmaceuticals (Nasdaq: JAZZ) has announced its participation in two major investor conferences in June 2025. The company will join the Jefferies Global Healthcare Conference on June 5, with a fireside chat scheduled for 6:55 a.m. PDT, and the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, featuring a fireside chat at 7:00 a.m. PDT.

Audio webcasts of both presentations will be accessible through Jazz Pharmaceuticals' investor relations website, with recordings available for 30 days after the events. Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for serious diseases, with a portfolio spanning sleep disorders, epilepsy, and cancer treatments.

Jazz Pharmaceuticals has announced its participation in the upcoming BofA Securities 2025 Healthcare Conference. The company's management will engage in a fireside chat scheduled for May 14, 2025, at 10:00 a.m. PT / 1:00 p.m. ET / 6:00 p.m. IST.

The event will be accessible via audio webcast through the Investors section of Jazz Pharmaceuticals' website, with a 30-day replay available. Jazz Pharmaceuticals, listed on Nasdaq as JAZZ, is a global biopharma company focused on developing life-changing medicines for patients with serious diseases, particularly in areas with limited treatment options.

The company maintains a diverse portfolio including:

• Leading therapies for sleep disorders and epilepsy
• Growing portfolio of cancer treatments
• Innovative pipeline in oncology and neuroscience

Headquartered in Dublin, Ireland, Jazz operates research and development laboratories and manufacturing facilities across multiple countries.

Jazz Pharmaceuticals (JAZZ) has received a positive opinion from the European Medicines Agency's CHMP for zanidatamab, a dual HER2-targeted bispecific antibody. The recommendation is for treating adults with unresectable locally advanced or metastatic HER2-positive biliary tract cancer who have received prior systemic therapy.

The recommendation is based on data from the Phase 2b HERIZON-BTC-01 trial. If approved, zanidatamab would become the first HER2-targeted therapy for this rare cancer in the EU. The drug previously received FDA accelerated approval in November 2024 under the brand name Ziihera®.

Biliary tract cancers affect less than 1% of all adult cancers worldwide, with approximately 26% of patients being HER2-positive. Across the U.S., Europe, and Japan, about 12,000 people are diagnosed with HER2+ BTC annually. The European Commission will now review the CHMP's recommendation for final approval decision.