Vera Therapeutics reports 76% lower kidney-progression risk for Trutakna

  • Vera Therapeutics reported final ORIGIN3 results for Trutakna in primary IgA nephropathy.
  • 76% lower progression risk was recorded through 104 weeks, with 11 events versus 38.
  • Vera plans a fourth-quarter supplemental Biologics License Application after accelerated FDA approval.

Vera Therapeutics reported final ORIGIN3 results showing Trutakna (atacicept-vymj) met all prespecified endpoints in 428 adults with primary IgA nephropathy. The treatment reduced the risk of composite kidney disease progression by 76% through 104 weeks, with 11 events versus 38 for placebo, and kept the annualized eGFR decline to -0.6 mL/min/1.73m² per year versus -5.6 for placebo. The placebo-adjusted eGFR slope difference was 5.0 mL/min/year, broadly consistent with kidney-function decline associated with normal aging. No Trutakna patients underwent dialysis for at least 30 days, received a kidney transplant or died during the period, versus eight placebo patients. Vera shares rose 4% to $35.39 on Tuesday but remained down 34% year to date. The FDA granted Trutakna accelerated approval in July based on its effect on urinary protein, and Vera plans to submit a supplemental Biologics License Application in the fourth quarter for full approval. TD Cowen retained a Buy rating and $78 price target, while analysts cited competition from Otsuka’s Voyxact and Vertex’s povetacicept.

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Vera Therapeutics reports 76% lower kidney-progression risk for Trutakna - CoinPost Terminal