AstraZeneca Gets Accelerated FDA Nod for Ultomiris in IgA Nephropathy

What happened: The FDA granted accelerated approval to AstraZeneca's Ultomiris (ravulizumab) for reducing proteinuria in adults with primary IgA nephropathy at risk of disease progression. Why it matters: The approval adds a fifth U.S. indication for Ultomiris and puts it in competition with Tarpeyo, Fabhalta and Filspari. Whether Ultomiris slows kidney function decline is not yet established; the I CAN study's eGFR results are intended to support traditional approval. Market: +2.8% today ($173.24), -4.4% YTD, 0.4x vol — as of 15:47 UTC

The FDA granted accelerated approval to AstraZeneca's Ultomiris (ravulizumab) for reducing proteinuria in adults with primary IgA nephropathy at risk of disease progression.

The approval adds a fifth U.S. indication for Ultomiris and puts it in competition with Tarpeyo, Fabhalta and Filspari. Whether Ultomiris slows kidney function decline is not yet established; the I CAN study's eGFR results are intended to support traditional approval. Market: +2.8% today ($173.24), -4.4% YTD, 0.4x vol — as of 15:47 UTC