熱門資訊> 正文
阿佩利斯因肾病治疗获得FDA优先审查
2025-04-01 21:26
- Apellis Pharmaceuticals (APLS) said on Tuesday that the U.S. FDA has accepted and granted Priority Review designation for EMPAVELI to treat two rare and severe kidney diseases.
- The FDA has set Prescription Drug User Fee Act target action date of July 28, 2025 for EMPAVELI as a treatment for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis.
- The Supplemental New Drug Application submission was based on positive late-stage trial results, which showed consistent benefits across different patient groups, including adolescents, adults, and those with native or transplanted kidneys.
- Stock is up 2.6% premarket.
More on Apellis Pharmaceuticals
- Apellis Pharmaceuticals: A Mixed Bag
- Apellis Pharmaceuticals, Inc. (APLS) Q4 2024 Earnings Call Transcript
- Apellis Pharmaceuticals, Inc. 2024 Q4 - Results - Earnings Call Presentation
- Apellis stock jumps 8% on preliminary Q4 results, updates
- Seeking Alpha’s Quant Rating on Apellis Pharmaceuticals
推薦文章
風險及免責提示：以上內容僅代表作者的個人立場和觀點，不代表華盛的任何立場，華盛亦無法證實上述內容的真實性、準確性和原創性。投資者在做出任何投資決定前，應結合自身情況，考慮投資產品的風險。必要時，請諮詢專業投資顧問的意見。華盛不提供任何投資建議，對此亦不做任何承諾和保證。
