# TRUTAKNA (atacicept-vymj) PDUFA Event: Primary IgA nephropathy

Canonical URL: https://biopharmsignal.com/pdufa-calendar/VERA/atacicept-iga-nephropathy

Ticker: VERA

Company: Vera Therapeutics

Event date: 2026-07-07

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-07-07

Application type: BLA

FDA granted accelerated approval to TRUTAKNA. FDA granted accelerated approval to TRUTAKNA to reduce proteinuria in adults with primary IgA nephropathy at ri...

## Event Timeline

### July 7, 2026 — 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](https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-receives-fda-accelerated-approval-trutaknatm)

### June 2, 2026 — 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](https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-alignment-us-fda-earlier-origin)

### January 7, 2026 — 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](https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-us-fda-granted-priority-review)

### November 7, 2025 — 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](https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-submits-biologics-license-application-us-fda)

### November 6, 2025 — ORIGIN 3 results were presented and published

The week 36 analysis showed a 46% reduction in proteinuria from baseline and a 42% reduction versus placebo, with results presented at ASN Kidney Week and published in the New England Journal of Medicine.

[Vera Therapeutics — ORIGIN 3 presentation and publication](https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-positive-origin-phase-3-data)

### June 2, 2025 — ORIGIN 3 met its primary endpoint

The Phase 3 trial met its week 36 proteinuria endpoint, and Vera said the safety profile was favorable and comparable to placebo.

[Vera Therapeutics — Positive ORIGIN 3 topline results](https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-atacicept-achieved-46-proteinuria/)

### May 28, 2024 — FDA granted Breakthrough Therapy designation

FDA granted Breakthrough Therapy designation to atacicept for IgA nephropathy based on Phase 2b ORIGIN data.

[Vera Therapeutics — Breakthrough Therapy designation](https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-receives-us-fda-breakthrough-therapy/)

## Regulatory Designations

- Priority Review FDA: [Vera Therapeutics — FDA acceptance, Priority Review and July 7 PDUFA date](https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-us-fda-granted-priority-review)

- Breakthrough Therapy FDA: [Vera Therapeutics — Breakthrough Therapy designation for atacicept in IgAN](https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-receives-us-fda-breakthrough-therapy/)

## Related Pages

- VERA PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/VERA.md

- VERA company profile: https://biopharmsignal.com/company/VERA.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-09-04 — Vera Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/VERA/vera-therapeutics-announces-inducement-grants-under-nasdaq-listing-rule-5635-c-4-4d192483.md

- 2026-09-01 — Vera Therapeutics to Participate at Upcoming Investor Conferences: https://biopharmsignal.com/news/VERA/vera-therapeutics-to-participate-at-upcoming-investor-conferences-3becca75.md

- 2026-08-10 — Vera Therapeutics Provides Business Update and Reports Second Quarter 2026 Financial Results: https://biopharmsignal.com/news/VERA/vera-therapeutics-provides-business-update-and-reports-second-quarter-2026-finan-5bd51126.md

- 2026-08-07 — Vera Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/VERA/vera-therapeutics-announces-inducement-grants-under-nasdaq-listing-rule-5635-c-4-9375a39d.md

- 2026-07-10 — Vera Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/VERA/vera-therapeutics-announces-inducement-grants-under-nasdaq-listing-rule-5635-c-4-81ab24dd.md