The Vertex kidney drug povetacicept is successful in the study for IgAN
A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston.
Brian Snyder | Reuters
Vertex Pharmaceuticals said its experimental drug for a rare kidney disease successfully passed a Phase 3 trial, a key step in the company’s journey to diversify beyond its main cystic fibrosis drugs.
The Boston-based drugmaker said Monday that its immunoglobulin A nephropathy drug, povetacicept, reduced levels of a marker of the autoimmune disease by 52% in a late-stage trial. That exceeded the bar set by analysts for Vertex’s drug to compete with a recently approved drug from Japan’s Otsuka and another in the pipeline from the U.S. biotech company Vera Therapeutics. Shares of Vertex rose more than 9% on Tuesday.
“Vertex’s successful study is an important first step toward entering a new market segment in kidney disease,” said Carter Gould, analyst at Cantor Fitzgerald. Vertex is developing two drugs behind povetacicept, and Gould expects the three to generate combined annual sales of more than $10 billion. That could rival Vertex’s cystic fibrosis franchise, which brought in more than $11 billion in sales last year.
“You don’t have to look really hard to see the connections and say this is a pretty meaningful white space that they could grow into,” Gould said.
Vertex has revolutionized the treatment of cystic fibrosis with a portfolio of drugs for the inherited lung disease, but the company has repeatedly faced questions about whether it could replicate that success in other diseases. The company has expanded into blood disorders in recent years with the approval of its gene-editing drug Casgevy and into acute pain with its drug Journavx. Neither has been a resounding success, forcing Vertex to look for other expansion opportunities.
In 2024, Vertex paid nearly $5 billion to acquire Alpine Immune Sciences and its lead program Povetacicept. The drug could treat a rare autoimmune disease called IgAN, which affects the kidneys’ ability to function properly and sometimes causes patients to need dialysis or even a transplant. Vertex also plans to test the drug for several other kidney diseases.
The company expects to complete its application to the U.S. Food and Drug Administration for povetacicept in IgAN by the end of this month. Approval is possible later this year with the use of a priority review voucher.
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