Vera Therapeutics Moves Closer To Full Approval For Kidney Disease Drug After FDA Alignment

• Key kidney function data from the ORIGIN 3 study is expected in Q3 2026, with a potential full approval filing planned for Q4 2026.
• The updated timeline was supported by prior Phase 2b findings and discussions involving regulators, researchers, clinicians, and patient advocates.
• Atacicept works by targeting BAFF and APRIL, two immune-system proteins linked to IgA nephropathy and other autoimmune diseases.

Vera Therapeutics (VERA) said on Tuesday it has reached an agreement with the U.S. Food and Drug Administration (FDA) on an earlier analysis plan for the ORIGIN 3 late-stage trial, a move that could accelerate the path to full approval of atacicept for adults with IgA nephropathy (IgAN).

Despite the regulatory update, VERA shares fell in morning trading. They were down 5.8% at the time of writing.

Phase 3 Data Now Due In Q3 2026

Vera Therapeutics announced that the key kidney function results from its large Phase 3 ORIGIN 3 clinical trial are now expected in the third quarter of 2026. If the results are positive, the company plans to submit a supplemental Biologics License Application (sBLA) seeking full FDA approval for atacicept in the fourth quarter of 2026. Vera submitted a Biologics License Application (BLA) for accelerated approval of atacicept in November 2025. The supplemental application will seek to change the accelerated approval, if granted, to a full approval.  

The revised analysis timeline follows discussions with the FDA and comes after a recent National Kidney Foundation workshop that brought together clinicians, researchers, regulators, and patient advocates. The agency's agreement was also supported by encouraging eGFR findings from the Phase 2b ORIGIN trial.

“We are excited about the potential to bring the first approved therapy targeting both BAFF and APRIL to adults with IgA nephropathy and to potentially support full approval of atacicept sooner,” said Marshall Fordyce, founder and CEO of Vera Therapeutics. 

Kidney Disease Drug Delivers Across Trials

Atacicept is an experimental medicine. It is a lab-made protein that sticks to and blocks two natural body signals called BAFF and APRIL. BAFF and APRIL help certain immune cells (called B cells) survive and make harmful antibodies that attack the body’s own tissues. By blocking these signals, atacicept aims to calm the overactive immune response in IgA nephropathy and other autoimmune diseases.

The ORIGIN Phase 2b trial met its primary and key secondary goals, showing reduced proteinuria and stable kidney function compared with placebo through 36 weeks. The Phase 3 ORIGIN trial also met its primary endpoint, showing a reduction in proteinuria at week 36 in a prespecified interim analysis.

Atacicept has received the FDA's Breakthrough Therapy Designation for IgA nephropathy and has been administered to more than 1,500 patients across clinical trials in multiple disease areas. 

VERA Stock: What Retail Sentiment Says

Sentiment around VERA on Stocktwits improved to “neutral” on Tuesday from “bearish” a day ago, and message volume has been “normal.”

The VERA stock has been down nearly 40% year-to-date. 

For updates and corrections, email newsroom[at]stocktwits[dot]com.