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FDA Lets Vera Analyze Atacicept Phase 3 Data a Year Early as Accelerated Approval Decision Nears
Vera Therapeutics reached an agreement with the FDA to speed up analysis of its confirmatory Phase 3 study for atacicept in IgA nephropathy. A decision on accelerated approval is expected by July 7.
Jun 2, 11:08 AM·1m read1 source
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Vera Therapeutics reached an agreement with the FDA to accelerate analysis of its confirmatory Phase 3 study for atacicept in IgA nephropathy. The drug is already under review for accelerated approval, with a decision expected by July 7. The new agreement allows Vera to analyze the Phase 3 study in the third quarter rather than waiting for an additional year of data.
Convergent Therapeutics demonstrated that its experimental therapy could extend the lives of prostate cancer patients even after chemotherapy and Novartis' radiation therapy Pluvicto stopped working. Abivax said its experimental treatment for ulcerative colitis showed significant efficacy in a maintenance trial. The data were announced on June 1, 2026.
The article was published on June 2, 2026 by Elaine Chen, National Biotech Reporter at STAT. Chen co-writes The Readout newsletter and co-hosts STAT’s weekly biotech podcast The Readout Loud. com.
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