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.

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