FDA Grants Priority Review to Vera Therapeutics' Atacicept for IgA Nephropathy

Reuters01-07

FDA Grants Priority Review to Vera <a href="https://laohu8.com/S/LENZ">Therapeutics</a>' Atacicept for IgA Nephropathy

Vera Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN), granting it Priority Review status. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026. If approved, atacicept would become the first B cell modulator targeting both BAFF and APRIL for IgAN. The BLA submission is supported by positive interim results from the ORIGIN 3 trial, showing significant reductions in proteinuria and a favorable safety profile. Atacicept has also received FDA Breakthrough Therapy Designation for the treatment of IgAN.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vera Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9621196-en) on January 07, 2026, and is solely responsible for the information contained therein.

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The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026. If approved, atacicept would become the first B cell modulator targeting both BAFF and APRIL for IgAN. The BLA submission is supported by positive interim results from the ORIGIN 3 trial, showing significant reductions in proteinuria and a favorable safety profile. Atacicept has also received FDA Breakthrough Therapy Designation for the treatment of IgAN.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vera Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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