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Vera Therapeutics Presents Final Results of TRUTAKNA ORIGIN 3 Trial
Vera Therapeutics announced that the final efficacy analysis for the ORIGIN 3 trial of TRUTAKNA in adults with primary IgA nephropathy at risk for disease progression was presented as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology Kidney Week 2026 and simultaneously published in The New England Journal of Medicine. ORIGIN 3 met the primary endpoint of statistically significant proteinuria reduction at 36 weeks. In the final efficacy analysis, TRUTAKNA achieved statistical significance in all prespecified endpoints.TRUTAKNA also achieved statistically significant reductions in urine-protein to creatinine ratio, galactose-deficient IgA1, and hematuria. TRUTAKNA was well tolerated with a favorable safety profile generally comparable to placebo, consistent with previous safety data from the ORIGIN program. Adverse events occurred in 160/214 patients on TRUTAKNA and 167/214 on placebo. The rate of serious adverse events in the TRUTAKNA group was 7% compared with 15% in the placebo group. Infection rates were similar between TRUTAKNA and placebo groups, and no clinically relevant hypogammaglobulinemia or opportunistic infections were observed. There was 1 death in the placebo group and no deaths in the TRUTAKNA group. No clinically meaningful effect of anti-drug antibodies on efficacy or overall safety was identified.
Stock Futures Lower Ahead of Fed Policy Meeting
Stock futures are pointing to another lower open as investors brace for the Federal Reserve to begin its two-day policy meeting, with the central bank widely expected to raise interest rates for the first time since 2023. The 10-year Treasury yield has climbed above 5% for the first time since 2007, reaching about 5.04%, as investors contend with renewed inflation concerns, elevated government borrowing and the prospect of tighter monetary policy.Oil is adding to the inflationary pressure, with Brent crude around $107 a barrel and WTI above $103 as disruptions to Middle Eastern energy infrastructure continue. Saudi Arabia's East-West pipeline remains shut following attacks, while uncertainty surrounding the conflict and oil flows through the region is keeping a substantial geopolitical premium in crude prices.Markets are now pricing roughly a 92%-94% probability of a 25-basis-point Fed hike on Wednesday, which would take the federal-funds target range to 3.75%-4%.In pre-market trading, S&P 500 futures fell 0.13%, Nasdaq futures fell 0.13% and Dow futures fell 0.26%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Vera Therapeuticsup 16% after reporting that trutakna met all prespecified endpoints of the final efficacy analysis of the ORIGIN 3 trial in adults with primary IgA nephropathyEtsyup 3% after Oppenheimer upgraded shares to Outperform with a $90 price targetEli Lillyup 1% after Berenberg upgraded the stock to Buy with a price target of $1,400, up from $1,220UP AFTER EARNINGS -Vera Bradleyup 12%Forgent Power Solutionsup 8%DOWN AFTER EARNINGS -Dave and Buster'sdown 12%Kestra Medicaldown 9%LOWER -Enovadown 20% after withdrawing its applications with the Office of the Comptroller of the Currency and the Board of Governors of the Federal Reserve System related to the proposed acquisition of Grasshopper BancorpSyscodown 2% after a $1B secondary share offering priced at $81 per share
Vera Therapeutics Stock Up 13% in Pre-Market at $38.63
Vera Therapeutics up 13% in pre-market at $38.63 after trutakna ORIGIN 3 data
Vera Therapeutics Announces Trutakna Met All Endpoints in ORIGIN 3 Trial
Vera Therapeutics announced that trutakna met all prespecified endpoints of the final efficacy analysis of the ORIGIN 3 trial in adults with primary IgA nephropathy, or IgAN, at risk for disease progression. IgAN is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide. Trutakna, the first and only FDA-approved BAFF and APRIL inhibitor, met all prespecified endpoints, including unprecedented placebo-adjusted estimated glomerular filtration rate, or eGFR, and composite kidney disease progression benefits. These eGFR results align with the KDIGO treatment goal to reduce the rate of kidney function decline to the physiologic rate. Trutakna also achieved statistically significant reductions in the hierarchically tested endpoints of proteinuria, galactose-deficient IgA1 and hematuria. Trutakna was well tolerated with a favorable safety profile generally comparable to placebo, consistent with previous results from the ORIGIN program. Rates of overall adverse events and infections or infestations were similar between the trutakna and placebo groups, and there were no opportunistic infections or clinically relevant hypogammaglobulinemia. Detailed results from the final efficacy analysis will be shared at an upcoming scientific congress. The company plans to submit supplemental BLA to the FDA for full approval in Q4.
Vera Therapeutics Launches TRUTAKNA for IgAN Patients
"The accelerated approval and commercial launch of TRUTAKNA represent transformative milestones for Vera Therapeutics and are the result of years of hard work and dedication. We are extremely grateful to the patients, investigators, employees, and collaborators who have contributed to this moment," said Marshall Fordyce, Founder and Chief Executive Officer of Vera Therapeutics. "We are thrilled that TRUTAKNA is available to eligible patients as the first and only therapy to inhibit both BAFF and APRIL in IgAN patients. We are focused on a successful U.S. launch of TRUTAKNA, and we continue to advance the ORIGIN 3 program in support of a potential full approval."
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