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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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