Jazz Pharmaceuticals Plc Stock Price, News & Analysis

Jazz Pharmaceuticals (NASDAQ: JAZZ) will host an investor webcast on August 27, 2025, at 4:30 p.m. EDT to discuss Modeyso™ (dordaviprone), their newly approved treatment for diffuse midline glioma. The presentation will feature insights from Jazz's senior management and Dr. Timothy Cloughesy, distinguished professor from UCLA Brain Tumor Center.

Notably, Modeyso received FDA accelerated approval on August 6, 2025, becoming the first and only approved treatment for patients aged 1 and older with H3 K27M-mutant diffuse midline glioma who have progressive disease after prior therapy. The webcast will cover clinical data, patient needs, and commercialization strategy for this breakthrough treatment.

Jazz Pharmaceuticals (Nasdaq: JAZZ) has entered into a global licensing agreement with Saniona (Nasdaq OMX: SANION) for exclusive worldwide rights to develop and commercialize SAN2355, a preclinical asset for epilepsy treatment. Jazz will pay $42.5 million upfront to Saniona.

The agreement includes potential payments of up to $192.5 million in development and regulatory milestones, including $7.5 million for Phase 1 initiation, up to $800 million in commercial milestones, and tiered royalties from mid-single digits to low-double digits on net sales.

SAN2355 is a subtype-selective Kv7.2/Kv7.3 activator designed to overcome limitations of non-selective Kv7-targeting compounds. Jazz will lead and fund development, regulatory submissions, and global commercialization efforts.

Jazz Pharmaceuticals (NASDAQ: JAZZ) has achieved a groundbreaking milestone with the FDA's accelerated approval of Modeyso™ (dordaviprone), the first-ever treatment for H3 K27M-mutant diffuse midline glioma with progressive disease. This ultra-rare and aggressive brain tumor affects approximately 2,000 people annually in the U.S., primarily children and young adults.

The approval is based on clinical studies showing an overall response rate of 22% among 50 patients, with a median response duration of 10.3 months. Among responders, 73% maintained their response for at least six months. The safety evaluation, conducted across 376 patients, revealed serious adverse reactions in 33% of cases.

Modeyso, administered as a weekly oral capsule, will be commercially available in the coming weeks. Continued approval may depend on results from the Phase 3 ACTION confirmatory trial.

Jazz Pharmaceuticals (NASDAQ:JAZZ) reported Q2 2025 financial results with total revenues of $1.05 billion, up 2% year-over-year. The company announced leadership transition with Renee Gala appointed as President and CEO effective August 11. Key product performance included Xywav revenue growth of 13% to $415.3 million with 625 new patients added. The company faced challenges with GAAP net loss of $718.5 million, largely due to a $905.4 million IPR&D expense from the Chimerix acquisition.

Notable pipeline developments include Zepzelca's Priority Review for first-line ES-SCLC treatment and Ziihera's European approval for HER2-positive biliary tract cancer. The company updated its 2025 guidance, projecting total revenue of $4.15-$4.30 billion, representing 4% growth at midpoint. Jazz also executed $125 million in share repurchases during Q2.

Jazz Pharmaceuticals (NASDAQ: JAZZ), a global biopharma company, has announced it will release its 2025 second quarter financial results on Tuesday, August 5, 2025, after U.S. market close. The company will host a live audio webcast at 4:30 p.m. EDT / 9:30 p.m. IST to discuss the results and provide business updates.

Participants are encouraged to register at least 15 minutes before the webcast through the company's website or direct registration link. A replay will be available in the Investors section of Jazz Pharmaceuticals' website. The company specializes in developing medicines for sleep disorders, epilepsy, and cancer treatments, with operations spanning multiple countries.

Jazz Pharmaceuticals (NASDAQ: JAZZ) has announced that Renee Gala will become the company's new President and Chief Executive Officer, effective August 11, 2025. Gala, currently serving as President and COO, will succeed co-founder Bruce Cozadd, who will retire as CEO but continue as Board Chairperson.

Gala brings over 30 years of experience and has been instrumental in Jazz's transformation since joining as CFO in March 2020. Under her leadership as COO, the company achieved nearly 90% total revenue growth through portfolio diversification and strategic business development. The appointment follows a comprehensive succession planning process where the Board evaluated both internal and external candidates.

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.