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 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)