TRUTAKNA Hits All Endpoints in ORIGIN 3 Final Analysis — 76% Risk Reduction in Kidney Disease Progression
VERA sits 70% above its 52-week low of $22.72.
Summary
TRUTAKNA met all prespecified endpoints in the ORIGIN 3 final efficacy analysis, including a 76% reduction in kidney disease progression risk and stabilization of eGFR, supporting a supplemental BLA submission in Q4 2026.
Key Events · Product Development and Regulatory · VERA
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ORIGIN 3 Final Analysis Met All Endpoints
TRUTAKNA achieved a placebo-adjusted eGFR difference of 5.6 mL/min/1.73m² at 52 weeks and 5.0 mL/min/1.73m²/year in annualized slope through 104 weeks (both p<0.0001).
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76% Reduction in Kidney Disease Progression
Composite kidney disease progression events were 11 in TRUTAKNA vs 38 in placebo (HR 0.24, 95% CI 0.12-0.48), with zero dialysis/transplant/death events in the treatment arm versus 8 in placebo.
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Supplemental BLA Submission Planned Q4 2026
Company plans to submit a supplemental BLA for full approval in Q4 2026, with potential full approval in 2027, based on these final efficacy results.
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Commercial Launch Momentum
Over 350 patient start forms generated in the first 10 weeks since accelerated approval, with paid claims and favorable initial payer policies reported.
Analysis · VERA · Life Sciences
The final efficacy data from the ORIGIN 3 Phase 3 trial show TRUTAKNA stabilized eGFR and cut the risk of composite kidney disease progression by 76% versus placebo. A placebo-adjusted eGFR difference of 5.6 mL/min/1.73m² at 52 weeks and zero dialysis/transplant/death events in the treatment arm are unprecedented results that support a supplemental BLA submission in Q4 2026 for full approval. This is the confirmatory evidence the FDA required under the accelerated approval granted in July 2026, and it materially de-risks the path to full approval and long-term commercial viability.
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At the time of this filing, VERA was trading at $38.64 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.5B. The 52-week trading range was $22.72 to $56.05. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.