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Calliditas的Kinpegyo获得欧盟批准，司塔纳西布研究达到终点
2024-07-27 03:52
- Calliditas (NASDAQ:CALT) said its partner STADA has received full EU marketing authorization for the drug Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy, or IgAN.
- Kinpeygo is marketed in the EU and UK by the company's commercial partner STADA Arzneimittel. Calliditas (CALT) said the approval will trigger a milestone payment of EUR 10M, which it plans to recognize in Q3.
- Calliditas (CALT) also reported that a Phase 2b study for its drug setanaxib in patients with primary biliary cholangitis and elevated liver stiffness met its primary endpoint.
- The company expects topline data from a Phase 2 study of setanaxib in idiopathic pulmonary fibrosis in Q4 2024/Q1 2025 and from a Phase 2 proof-of-concept study in Alport syndrome in 2025.
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