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Vertex Says FDA Granted Breakthrough Therapy Status for Immunoglobulin A Nephropathy Treatment
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Vertex Says FDA Granted Breakthrough Therapy Status for Immunoglobulin A Nephropathy Treatment
Sep 25, 2025 6:09 AM

08:48 AM EDT, 09/25/2025 (MT Newswires) -- Vertex Pharmaceuticals ( VRTX ) said Thursday that the US Food and Drug Administration granted breakthrough therapy designation to povetacicept, its investigational recombinant fusion protein therapeutic, for the treatment of immunoglobulin A nephropathy.

The company is currently evaluating povetacicept in a global phase 3 clinical study in participants with immunoglobulin A Nephropathy, it said.

Vertex said it has also started a 52-week phase 2 proof-of-concept trial of VX-407, an investigational small molecule corrector, to treat autosomal dominant polycystic kidney disease.

The company also said it completed enrollment in the interim analysis group of Amplitude, its phase 2/3 study to evaluate the effect of inaxaplin on kidney function and proteinuria for patients with apol1-mediated kidney disease.

Shares of the company were up 1.1% in recent Thursday premarket activity.

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