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HealthQuiet 9d · day 9

Vera's Trutakna shows strong Phase 3 results for IgA nephropathy

Final two-year data from the kidney drug trial support a full FDA approval bid in Q4.

newest coverage 8d agosummary written 8d ago5 pieces1 likes & upvotes NewswiresMastodonGoogle News

What to know

  • Vera's Trutakna met its primary endpoint in Phase 3 trial, stabilizing kidney function over two years in IgA nephropathy patients.
  • The drug previously received accelerated FDA approval in July; final data now support a full approval application in Q4 2026.
  • IgA nephropathy is a progressive autoimmune kidney disease that can lead to organ failure and dialysis without effective treatment.

Vera Therapeutics Drug developerFDA Regulatory authority

Vera's Trutakna shows strong Phase 3 results for IgA nephropathy
statnews.com

How it unfolded 1 development · click the chart to see its coverage articlesposts

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Sep 16Sep 17Sep 18Sep 19Sep 20Sep 21Sep 22yesterdaynow · 6:44 AM ET
  1. 1

    Vera releases final Phase 3 results showing kidney function stabilization

    Vera Therapeutics announced final, two-year results from the Phase 3 ORIGIN 3 trial, demonstrating that Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in IgAN patients. The company said it will seek full FDA approval during the fourth quarter based on these data.

    “Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in patients with a chronic autoimmune kidney disease…”
    — Vera Therapeutics

    1. 2 outlets first by STAT News, 9d ago · also STAT · read ↗

    2. 1 outlet Positive data positions Vera's IgA nephropathy drug Trutakna for full approval

      first by FirstWord Pharma, 8d ago

    • STAT

      Vera Therapeutics said that its recently approved drug Trutakna stabilized kidney function and reduced the risk of kidney-related death and other complications in patients with a chronic autoimmune kidney disease. https://www. statnews.com/2026/09/15/vera-k idney-drug-trutakna-shows-strong-phase-3-results-igan/

      STATMastodon8d ago1▲view on Mastodon ↗
  2. background

    FDA grants accelerated approval to Trutakna for IgA nephropathy — The Food and Drug Administration granted accelerated approval to Vera Therapeutics' Trutakna for treatment of IgA nephropathy, a disease caused by buildup of immune antibodies in the kidneys that leads to progressive loss of kidney function.