Tuesday, July 7, 2026
Approved
approved Note: Approved 2026-07-07 as TRUTAKNA (ORIG BLA761486). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-08-02; 0d from the PDUFA date.
Drug Information
- Drug Name
- Atacicept (CT.gov)
- Application Type
- BLA
- FDA Designations
- Priority Review
- Indication
- IgA nephropathy
- Approved As
- Atacicept
Filing Details
- Company
- Vera Therapeutics, Inc. →
- Stock Ticker
- VERA
- SEC CIK
- 0001831828
- Source
- Company IR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Explore Vera Therapeutics, Inc.
View Vera Therapeutics, Inc.'s full pipeline, approved drugs, and clinical trials.
Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue