Jazz Pharmaceuticals Plc Stock Price, News & Analysis

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.

Jazz Pharmaceuticals (NASDAQ: JAZZ) announced the presentation of seven abstracts at the upcoming ASCO Annual Meeting 2025, featuring significant clinical trial results for multiple oncology treatments.

Key highlights include:

• Phase 3 IMforte trial demonstrated statistically significant survival benefits for Zepzelca and atezolizumab combination in extensive-stage small cell lung cancer
• Four-year follow-up data for Ziihera in HER2-positive gastroesophageal cancer showing promising long-term outcomes
• New efficacy and safety data for dordaviprone in treating H3 K27M-mutant diffuse glioma patients

The company will host an investor webcast on June 10, 2025, at 4:30 p.m. ET to review Zepzelca data. The presentations span across multiple cancer types, including lung cancer, gastroesophageal cancer, and glioma, demonstrating Jazz's expanding oncology portfolio.

Jazz Pharmaceuticals (Nasdaq: JAZZ) has scheduled its 2025 first quarter financial results announcement for Tuesday, May 6, 2025, after U.S. market close. The company will host a live audio webcast at 4:30 p.m. ET / 9:30 p.m. IST to discuss the results and provide business updates.

The global biopharma company, headquartered in Dublin, focuses on developing life-changing medicines for serious diseases, with a portfolio including therapies for sleep disorders, epilepsy, and cancer treatments. Participants are advised to register 15 minutes before the scheduled webcast, which can be accessed through the Investors section of Jazz Pharmaceuticals' website.

Jazz Pharmaceuticals (NASDAQ: JAZZ) has completed the acquisition of Chimerix for $935 million in cash, making Chimerix a wholly owned subsidiary. The deal centers around dordaviprone, a novel first-in-class small molecule treatment for H3 K27M-mutant diffuse glioma.

The drug is currently under FDA Priority Review with a PDUFA date of August 18, 2025. If approved, it could become the first FDA-approved therapy for this condition and may qualify for a Rare Pediatric Disease Priority Review Voucher. The acquisition price was set at $8.55 per share in cash.

Dordaviprone is also being evaluated in the Phase 3 ACTION trial for newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients post-radiation treatment, potentially expanding its use to first-line treatment.

Jazz Pharmaceuticals (Nasdaq: JAZZ) has announced its participation in the 24th Annual Needham Healthcare Conference. The company's management will engage in a fireside chat scheduled for Wednesday, April 9, 2025, at 9:45 a.m. PT / 12:45 p.m. ET / 5:45 p.m. IST.

An audio webcast of the discussion will be accessible through the Investors section of Jazz Pharmaceuticals' website, with replays available for 30 days. The company, headquartered in Dublin, Ireland, is a global biopharma organization focused on developing life-changing medicines for patients with serious diseases, particularly in areas with therapeutic options.

Jazz maintains a diverse portfolio including:

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

Jazz Pharmaceuticals (JAZZ) has announced the presentation of seven abstracts from its neuroscience portfolio at the 77th Annual American Academy of Neurology Meeting in April 2025. Key highlights include updated results from the Phase 4 DUET trial for Xywav® oral solution, showing statistically significant improvements in patients with narcolepsy and idiopathic hypersomnia (IH).

The DUET trial demonstrated notable improvements in Epworth Sleepiness Scale scores, reduced sleep stage shifts, increased deep sleep, and reduced awakenings in adults with narcolepsy. For IH patients, improvements were observed in ESS and Idiopathic Hypersomnia Severity Scale scores.

Additionally, a novel analysis of Epidiolex® real-world treatment patterns revealed nearly 70% persistence rate at one year among new patients. The data showed that 52% of patients took dosages >15 mg/kg/day at 12 months, with those taking >20 mg/kg/day showing the lowest discontinuation rates.

Jazz Pharmaceuticals (JAZZ) has announced the acquisition of Chimerix for $8.55 per share, representing a total cash consideration of $935 million - a 72% premium over Chimerix's closing price on March 4, 2025. The transaction is expected to close in Q2 2025.

The acquisition centers on dordaviprone, Chimerix's lead clinical asset, a first-in-class treatment for H3 K27M-mutant diffuse glioma, a rare brain tumor affecting children and young adults. The FDA has granted Priority Review for dordaviprone with a PDUFA date of August 18, 2025. If approved, it would be the first FDA-approved therapy specifically for this condition.

The drug is also being evaluated in the ongoing Phase 3 ACTION trial for newly diagnosed patients. Jazz plans to leverage its development and commercial capabilities for a potential launch in the second half of 2025, with patent protection extending to 2037.

Jazz Pharmaceuticals (NASDAQ: JAZZ) reported strong financial results for 2024, achieving record total revenues of $4.1 billion, a 6% year-over-year growth. The company's Q4 2024 revenues reached $1.1 billion.

Key performance highlights include:

• Xywav revenues grew 16% to $1.47 billion in 2024
• Epidiolex revenues increased 15% to $972.4 million
• Oncology revenues surpassed $1.1 billion, growing 9%
• GAAP net income was $560.1 million ($8.65 per diluted share)
• Non-GAAP adjusted net income reached $1.37 billion ($20.90 per diluted share)

The company generated $1.4 billion in cash from operations and ended 2024 with $3.0 billion in cash and investments. For 2025, Jazz provided revenue guidance of $4.15-$4.40 billion, representing 5% growth at the midpoint.

Jazz Pharmaceuticals (Nasdaq: JAZZ) has announced its participation in TD Cowen's 45th Annual Health Care Conference. The company's management will engage in a fireside chat scheduled for March 5, 2025, at 7:30 a.m. PT / 10:30 a.m. ET / 3:30 p.m. GMT.

The event will be accessible via audio webcast through the Investors section of Jazz Pharmaceuticals' website, with recordings available for 30 days post-event. Jazz Pharmaceuticals is a global biopharma company focused on developing life-changing medicines for patients with serious diseases, particularly in areas with therapeutic options.

The company maintains a diverse portfolio of marketed medicines, specializing in sleep disorders and epilepsy treatments, along with an expanding cancer treatment portfolio. Their research and development efforts span both oncology and neuroscience, with operations and facilities across multiple countries, headquartered in Dublin, Ireland.