Vera Therapeutics stated that Trutakna’s commercial launch generated more than 350 patient start forms in the first 10 weeks.
- No patients receiving Trutakna experienced dialysis lasting at least 30 days.
- Trutakna may help patients avoid dialysis, transplantation, or kidney-related death over the long term.
- Vera plans to submit a supplemental biologics license application in Q4 2026 for full FDA approval.
Vera Therapeutics Inc. (VERA) shares surged in Tuesday’s premarket trading after the company reported positive final Phase 3 results for Trutakna in adults with IgA nephropathy.
Trutakna is Vera’s treatment for IgA nephropathy, a progressive kidney disease that can lead to kidney failure. Vera said the treatment met all prespecified endpoints in the ORIGIN 3 trial, including measures of kidney function and disease progression.
VERA stock was up around 16% in the premarket and was among the top-trending tickers on Stocktwits at the time of this writing.
Trutakna Stabilized eGFR Through Two Years
Vera said estimated glomerular filtration rate (eGFR), a measure of kidney function, declined by 0.6 mL/min/1.73m² per year with Trutakna through 104 weeks, compared with a 5.6 mL/min/1.73m² annual decline with placebo.
The company also reported 11 composite kidney disease progression events in the Trutakna group compared with 38 in the placebo group, representing a 76% reduction in risk.
No patients receiving Trutakna experienced dialysis lasting at least 30 days, kidney transplantation, or death through 104 weeks, compared with eight patients in the placebo group. The treatment was well tolerated and had a favorable safety profile generally comparable with placebo, Vera said.
Trutakna Results Seen As A ‘Milestone’ In IgAN Treatment
Richard Lafayette, M.D., a principal investigator for ORIGIN 3 and professor of medicine at Stanford University Medical Center, said the final analysis “marks a milestone in IgAN treatment,” citing reduced kidney disease progression, stabilized eGFR, and a favorable safety profile through two years.
“Trutakna may help patients avoid dialysis, transplantation, or kidney-related death over the long term,” Lafayette said.
Vera plans to present detailed results from the final efficacy analysis at an upcoming scientific congress.
Full Approval Filing Planned For Q4
Trutakna is currently approved under the Food and Drug Administration’s accelerated approval pathway to reduce proteinuria in adults with primary IgAN at risk for disease progression.
Vera plans to submit a supplemental biologics license application to the FDA in the fourth quarter of 2026 for full approval, and said it looks forward to the potential full approval in 2027.
“In the first ten weeks, we have generated over 350 patient start forms. We are seeing paid claims and are pleased with initial payer policies. The early momentum of the Trutakna launch is very encouraging,” said Matt Skelton, Chief Commercial Officer of Vera Therapeutics.
What Retail Investors Think About VERA Stock
Retail sentiment around VERA stock turned “bullish” amid high message volume.
So far this year, Vera stock has fallen nearly 30%. In comparison, the State Street SPDR S&P Biotech ETF (XBI), which holds Vera stock, has risen 29.6% in the same period.
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