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Vertex IgA肾病资产povetacicept获得FDA滚动审查
2025-10-17 22:23
- The US FDA has granted a rolling review for the BLA for Vertex Pharmaceuticals' (NASDAQ:VRTX) povetacicept, a candidate for IgA nephropathy.
- The company plans to submit the first set of data to the FDA by the end of the year with the entire BLA submission completed by H1 2026.
- Povetacicept is considered a recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines.
- Vertex also noted that it started a phase 2b/3 trial of povetacicept in primary membranous nephropathy.
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