TRUTAKNA (atacicept-vymj)
Primary IgA nephropathy · Adults with primary IgA nephropathy at risk for disease progression
VERA · Vera Therapeutics
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7 件のマイルストーンFDA granted accelerated approval to TRUTAKNA
FDA granted accelerated approval to TRUTAKNA to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. The approval was based on the prespecified week 36 interim analysis of ORIGIN 3; continued approval may depend on confirmation of clinical benefit from the ongoing kidney-function analysis.
Vera Therapeutics — TRUTAKNA accelerated approval↗FDA aligned on an earlier ORIGIN 3 kidney-function analysis
Vera said FDA agreed to a revised ORIGIN 3 eGFR analysis planned for the third quarter of 2026 to support a potential supplemental BLA for full approval.
Vera Therapeutics — Alignment on earlier ORIGIN 3 analysis↗FDA accepted the BLA with Priority Review
FDA accepted the accelerated-approval BLA, granted Priority Review and assigned a July 7, 2026 PDUFA target action date.
Vera Therapeutics — BLA acceptance and Priority Review↗Vera submitted the BLA
Vera submitted the atacicept BLA through the FDA Accelerated Approval Program using the prespecified ORIGIN 3 interim analysis.
Vera Therapeutics — Atacicept BLA submission↗関連ニュース
Vera Therapeutics Provides Business Update and Reports Second Quarter 2026 Financial Results
2026年8月7日Vera Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
2026年7月10日Vera Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
2026年7月9日Vera Therapeutics Announces Appointment of Nancy Boman as Chief Regulatory Officer and Planned Retirement of William Turner
2026年7月7日Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy