Record mula sa primary source
MateryalNaisumite ang aplikasyon
Jazz Pharmaceuticals: Nakaplanong pagsumite ng Zanidatamab sBLA sa 1H26 para sa 1L GEA
Plano ng Jazz Pharmaceuticals na magsumite ng supplemental Biologics License Application (sBLA) para sa zanidatamab sa first-line (1L) GEA sa unang kalahati ng 2026. Ang pagsumiteng ito ay batay sa positibong datos mula sa Phase 3 HERIZON-GEA-01 study, na nagmumungkahi na ang zanidatamab kasama ang chemotherapy ay maaaring maging bagong standard of care para sa HER2+ GEA.
Mahahalagang fact
- Na-file
- Ene 12, 2026, 02:01 PM
- Kaganapan
- Naisumite ang aplikasyon
- Direksyon
- Positibo
- Kumpanya
JAZZJazz Pharmaceuticals- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
EX-99.1 2 d61589dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 January 2026 44th Annual J.P. Morgan Healthcare Conference Redefining Possibilities in Rare Disease Renee Gala, President & CEO Transforming Lives. Redefining Possibilities. Caution Concerning Forward-Looking Statements This presentation contains forward-looking statements and financial targets, including, but not limited to, statements related to: the Company’s growth prospects and future financial and operating results, including the ability of the Company’s portfolio to drive long-term shareholder value; expectations with respect to indication expansion opportunities; 2025 total revenue guidance and 2025 revenue for each of Xywav, Epidiolex and Modeyso and the Company’s expectations related thereto; the Company’s ability to dri