Shares of Vera Therapeutics (VERA) surged 9.4% to $37.25 in premarket trading on Tuesday after the company reported strong efficacy data from its confirmatory Phase 3 ORIGIN 3 trial. The stock had closed at $34.05 on Monday. The positive results mark a significant step toward converting the drug's accelerated approval into full FDA approval.
The ORIGIN 3 trial evaluated TRUTAKNA (atacicept) in adults with primary IgA nephropathy (IgAN), a rare kidney disease. The study met its primary endpoint, showing that TRUTAKNA significantly slowed the decline in kidney function compared to placebo. At week 52, the mean change in estimated glomerular filtration rate (eGFR) was nearly flat in the TRUTAKNA group (-0.1 mL/min/1.73m²) versus a decline of -5.7 mL/min/1.73m² in the placebo group, a difference of 5.6 mL/min/1.73m² (p<0.0001).
The benefit was sustained over two years. The annualized eGFR slope through week 104 was -0.6 mL/min/1.73m²/year for TRUTAKNA versus -5.6 for placebo, a difference of 5.0 mL/min/1.73m²/year (p<0.0001). These results directly address the unresolved question from the FDA's accelerated approval in July, which was based on reduction in proteinuria, a surrogate marker, rather than long-term kidney function outcomes.
Importantly, the composite progression endpoint—which included a sustained 30% decline in eGFR, end-stage kidney disease, dialysis, transplant, or death—showed a 76% reduction in risk for TRUTAKNA-treated patients. The hazard ratio was 0.24 (95% CI: 0.12-0.48), with 11 events in the treatment group versus 38 in the placebo group. Notably, eight placebo patients reached dialysis, transplant, or death, while none in the TRUTAKNA group did.
Safety data from the trial were consistent with previous studies. Vera reported that overall adverse events and infections were similar between groups, with no opportunistic infections or clinically relevant hypogammaglobulinemia. Detailed findings have not yet been presented at a scientific meeting or published in a peer-reviewed journal, so independent verification is pending.
The company plans to submit a supplemental Biologics License Application (sBLA) to the FDA in the fourth quarter for full approval, with a potential decision in 2027. The FDA will review the data and may request additional analyses, so the timeline is not guaranteed.
From a commercial perspective, Vera has reported 350 patient start forms in the first ten weeks since launch, which indicates early prescribing interest. However, start forms do not reflect actual prescriptions, revenue, or patient persistence. The company has not disclosed sales figures, but it noted that it is seeing paid claims and favorable initial payer policies.
Financially, Vera is well-positioned. As of June 30, the company had $499.2 million in cash, cash equivalents, and marketable securities, plus access to up to $425 million under a debt facility, subject to conditions. Operating cash burn in the first half was $206.8 million, and the second-quarter net loss was $109.5 million, so the company has sufficient runway to support the launch and regulatory activities.
Tuesday's data reduce the clinical uncertainty that had clouded the accelerated approval. The investment case now hinges on three key milestones: the detailed presentation of trial results, the FDA's acceptance and review of the sBLA, and the conversion of patient start forms into reimbursed, sustained use. While a favorable hazard ratio can support the label, only commercial execution can justify the revenue expectations embedded in Vera's valuation.
