Ami Fadia

David Amsellem

Gary Nachman

Andrea Newkirk

Annabel Samimy

Gregory Renza

Jason Gerberry

Jessica Fye

Joon Lee

Marc Goodman

Mohit Bansal

Joseph Thome

Akash Tewari

Amy Li

Jeffrey Hung

Troy Langford

Ashwani Verma

Charles Duncan

David Hoang

Joel Beatty

Michael Riad

Sean Laaman

- Jazz Pharmaceuticals plc entered into a **global settlement agreement** with Avadel Pharmaceuticals plc on **October 21, 2025**, resolving all patent infringement litigation and counterclaims between the parties.  **[1232524_0001193125-25-245815_d65147d8k.htm:1]** 
- As part of the settlement, Jazz will pay Avadel a **lump sum of $90 million** and expects to record a pre-tax charge of approximately **$90 million** in the **third quarter of 2025**.  **[1232524_0001193125-25-245815_d65147d8k.htm:1]** 
- The agreement includes Jazz granting Avadel licenses for its Lumryz product, with Avadel paying Jazz royalties of **3.85%** on net sales for Narcolepsy Indications starting **October 1, 2025**, and **10%** on net sales for Non-Narcolepsy Indications starting **March 1, 2028**.  **[1232524_0001193125-25-245815_d65147d8k.htm:1]** 
- Avadel also granted Jazz a covenant not to sue for infringement of any patents against Jazz's Xywav or Xyrem products.  **[1232524_0001193125-25-245815_d65147d8k.htm:1]**

Jazz Pharmaceuticals plc Settles Litigation with Avadel Pharmaceuticals plc

- Jazz Pharmaceuticals and Avadel Pharmaceuticals have announced a **global settlement** of all litigation between the two companies.  **[1232524_f69a1cd8c49a4a119de052ae8ecce4ed_0]** 
- Under the terms, Jazz will make a **$90 million payment** to Avadel and waive its right to receive royalties or damages on past sales of LUMRYZ through **September 30, 2025**.  **[1232524_f69a1cd8c49a4a119de052ae8ecce4ed_0]** 
- Avadel will pay Jazz ongoing royalties of **3.85%** (subject to potential reduction to 3.75%) of net sales of LUMRYZ in narcolepsy from **October 1, 2025**, through **February 18, 2036**.  **[1232524_f69a1cd8c49a4a119de052ae8ecce4ed_0]** 
- For future FDA-approved indications, such as idiopathic hypersomnia, LUMRYZ sales will be subject to a **10%** royalty (subject to potential reduction to 9.5%) of net sales until **February 18, 2036**, with sales for these indications beginning no earlier than **March 1, 2028**.  **[1232524_f69a1cd8c49a4a119de052ae8ecce4ed_0]**

Jazz Pharmaceuticals and Avadel Pharmaceuticals Reach Global Settlement

- The FDA has approved the **lurbinectedin (Zepzelca) and atezolizumab (Tecentriq) combination** as a **maintenance treatment** for adults with **extensive-stage small cell lung cancer (ES-SCLC)** whose disease has not progressed after first-line induction therapy.  **[1232524_57c97e0a4f5c434ea7ae2cbf9c1e9bdb]** 
- This approval, based on the Phase 3 IMforte trial, demonstrated the combination **reduced the risk of disease progression by 46%** and the **risk of death by 27%**, improving median overall survival from **10.6 to 13.2 months** and progression-free survival from **2.1 to 5.4 months**.  **[1232524_57c97e0a4f5c434ea7ae2cbf9c1e9bdb]** 
- This is the **first FDA-approved regimen** for maintenance therapy in ES-SCLC and has been incorporated as a **preferred treatment option in the NCCN guidelines**.  **[1232524_57c97e0a4f5c434ea7ae2cbf9c1e9bdb]** 
- The treatment is associated with a reported price tag of **around $8,110** and was generally well-tolerated in trials, despite treatment-related adverse events occurring in **83.5%** of patients receiving the combination versus 40% with atezolizumab alone.  **[1232524_57c97e0a4f5c434ea7ae2cbf9c1e9bdb]**

Jazz Pharmaceuticals' Zepzelca-Tecentriq Combination Receives FDA Approval

- **Jazz Pharmaceuticals** announced on **October 2, 2025**, that the **U.S. Food and Drug Administration (FDA)** granted approval for **Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®)** as the **first combination therapy for first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC)**.  **[1232524_20251002SF89623:0]** 
- This approval is based on results from the Phase 3 IMforte trial, where the combination **reduced the risk of disease progression or death by 46%** and the **risk of death by 27%** compared to atezolizumab maintenance therapy alone.  **[1232524_20251002SF89623:0]** 
- The median overall survival (OS) for the Zepzelca and atezolizumab regimen was **13.2 months** versus **10.6 months** for atezolizumab alone, and median progression-free survival (PFS) was **5.4 months** versus **2.1 months**, respectively.  **[1232524_20251002SF89623:0]** 
- The **National Comprehensive Cancer Network® Guidelines for SCLC** have been updated to include the Zepzelca and atezolizumab combination as a preferred regimen.  **[1232524_20251002SF89623:0]**

Jazz Pharmaceuticals Receives FDA Approval for Zepzelca Combination

- Jazz Pharmaceuticals received approval for **Dodavapene (Midaso)** prior to its PDUFA date, and the product is already serving patients with K27M mutant diffuse midline glioma.  **[1232524_tx_378143_1]** 
- The company has seen **strong results with Xywav**, including significant net patient adds in the second quarter of FY 2025, particularly in idiopathic hypersomnia.  **[1232524_tx_378143_1]** **[1232524_tx_378143_2]** 
- Jazz Pharmaceuticals anticipates results and readout for the **Horizon 301** frontline GEA study with Zanidatamab in **Q4 2025**, with three other Phase 3 studies for Zanidatamab also ongoing.  **[1232524_tx_378143_3]** 
- **Renée Galá** has been selected as the new CEO, replacing Bruce Cozadd.  **[1232524_tx_378143_1]** 
- The PDUFA date for the **Zepzelca** sNDA in combination with atezolizumab for extensive-stage small cell lung cancer is **October 7th**.  **[1232524_tx_378143_3]**

Jazz Pharmaceuticals discusses pipeline advancements and CEO transition

- Jazz Pharmaceuticals announced the **FDA approval** of Modesto (formerly dordapapril) on **August 6, 2025**, for H3K27M mutant diffuse midline glioma (DMG), followed by its **U.S. commercial launch** on **August 15, 2025**.  **[1232524_tx_376154_0]** **[1232524_tx_376154_1]** **[1232524_tx_376154_7]** 
- Modesto is the **first and only FDA-approved treatment** for this ultra-rare and aggressive brain tumor, which affects an estimated **2,000 patients annually** in the U.S..  **[1232524_tx_376154_1]** **[1232524_tx_376154_2]** **[1232524_tx_376154_9]** 
- The drug has a wholesale acquisition price (WAC) of **$32,000 per bottle** and **patent protection into February 2037**.  **[1232524_tx_376154_1]** **[1232524_tx_376154_10]**

Jazz Pharmaceuticals Announces FDA Approval and U.S. Launch of Modesto

Jazz Pharmaceuticals (JAZZ)