Vertex: FDA Grants Breakthrough Therapy Designation To Povetacicept
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Vertex Pharmaceuticals (VRTX) has received Breakthrough Therapy Designation from the FDA for povetacicept, aimed at treating IgAN. This investigational recombinant fusion protein is currently in a global Phase 3 trial named RAINIER. Additionally, Vertex completed enrollment for the IA cohort of the AMPLITUDE trial, which evaluates inaxaplin's effects on kidney function, potentially leading to accelerated approval in the U.S. The company also launched AGLOW, a Phase 2 study for VX-407 targeting ADPKD.
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