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Ionis对zilganersen获得FDA突破性治疗地位
2025-12-02 22:03
- Ionis Pharmaceuticals (IONS) has received breakthrough therapy designation from the U.S. FDA for its drug zilganersen, aimed at treating Alexander disease, a rare and often deadly neurological disorder.
- This designation is designed to speed up the review process for medications that address serious or life-threatening conditions and have shown early signs of significant improvement compared to existing treatments.
- Ionis is planning to file a New Drug Application with the U.S. FDA in the first quarter of 2026 and is also preparing to launch an Expanded Access Program in the United States.
More on Ionis Pharmaceuticals
- Ionis Pharmaceuticals, Inc. (IONS) Presents at Jefferies London Healthcare Conference 2025 Transcript
- Ionis Pharmaceuticals, Inc. (IONS) Presents at Stifel 2025 Healthcare Conference Transcript
- Ionis Pharmaceuticals, Inc. (IONS) Discusses Detailed Phase III Results for Olezarsen in Severe Hypertriglyceridemia - Slideshow
- Sanofi, Lilly among winners of EU drug recommendations this week
- Ionis announces proposed convertible offering to refinance 2026 convertible notes
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