Trutakna cuts kidney disease progression risk by 76% as Vera prepares to present results
Key Facts
Vera Therapeutics' Trutakna reduced the relative risk of kidney disease progression by 76%, according to final analysis results the company is preparing to discuss on October 22, 2026, alongside their presentation at Kidney Week. The company's filing with the U.S. Securities and Exchange Commission reported 11 disease progression events in the drug group, compared with 38 in the placebo group through week 104. The hazard ratio was 0.24 on the composite measure used to assess kidney disease progression. The company announced the topline results on September 15, 2026, saying at the time that the drug "met all prespecified endpoints" for the final analysis. The October presentation follows that announcement, while the drug's current accelerated approval is based on a reduction in proteinuria.
On kidney function, results attached to the company's filing showed an annual estimated glomerular filtration rate slope of minus 0.6 mL/min/1.73 square meters per year with Trutakna through week 104. The corresponding slope was minus 5.6 in the same units among participants who received placebo. The annual decline was therefore smaller with the drug, although the slope remained negative in both groups over the assessment period. The comparison was part of the "ORIGIN 3" study, which enrolled 428 adults with immunoglobulin A nephropathy, according to the prescribing information published on DailyMed. The prescribing information describes the study as randomized, double-blind and placebo-controlled, the design underpinning the comparison of outcomes between the treatment groups.
On safety, the investor presentation Vera submitted to the Securities and Exchange Commission reported adverse events in 75% of participants in the drug group. The corresponding rate was 78% in the placebo group in the final analysis. The prescribing information includes warnings about immunosuppression and infections. It specifies a Trutakna dose of 150 mg, administered by subcutaneous injection once weekly. The U.S. Food and Drug Administration's record lists the drug's original approval date as July 7, 2026. The prescribing information explains the basis for that decision, stating that the indication is "approved under accelerated approval based on a reduction in proteinuria," while the company lists its pursuit of full approval among its upcoming regulatory milestones.
In trading ahead of the scientific presentation, Vera shares closed the October 21, 2026, session at $31.20, according to historical prices published by Investing.com. The stock rose 3.79% in that session, ahead of the study results presentation at the October conference. The company scheduled the final analysis presentation at Kidney Week for October 22 at 9:05 a.m. U.S. Mountain Daylight Time. The scientific presentation follows the September announcement that the endpoints had been met and falls on the same day the company set aside to discuss the results with investors. Vera said in its statement published through GlobeNewswire that it would hold a live webcast of that discussion at 4:30 p.m. U.S. Eastern Time.
Vera expects to submit a supplemental biologics license application to the U.S. Food and Drug Administration in the fourth quarter of 2026, according to its business update filed with the Securities and Exchange Commission. The company lists potential full approval of Trutakna for immunoglobulin A nephropathy in 2027 among its anticipated milestones. That timing remains the company's expectation for the regulatory process, while the drug currently holds accelerated approval. On the financial calendar, Vera has scheduled its third-quarter earnings webcast for November 5, 2026. The financial results webcast is scheduled to begin at 4:30 p.m. U.S. Eastern Time, according to the company's statement.