The U.S. Food and Drug Administration on Tuesday granted accelerated approval to Vera Therapeutics Inc.'s (Vera Therapeutics (VERA)) Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.
Following the announcement, the stock jumped nearly 9%.
The approval was supported by interim Phase 3 data showing statistically significant reductions in proteinuria compared with placebo. Trutakna is approved under the FDA's accelerated approval pathway based on its ability to reduce proteinuria.
The company noted that long-term evidence demonstrating whether the treatment slows kidney function decline has not yet been established. Continued approval may depend on confirmation of clinical benefit in the ongoing ORIGIN 3 study.
Interim Trial Shows Significant Reduction In Proteinuria
The approval was supported by a prespecified interim analysis from the ongoing Phase 3 ORIGIN 3 trial involving the first 203 participants who received at least one dose of Trutakna or placebo.
Patients treated with Trutakna recorded a 46% reduction from baseline in urine protein-to-creatinine ratio (UPCR).
Compared with placebo, the therapy delivered a statistically significant 42% reduction in proteinuria at 36 weeks.
Ongoing Study
The ORIGIN 3 trial remains an ongoing study evaluating adults with IgA nephropathy.
Participants receive either once-weekly 150 mg subcutaneous Trutakna injections administered at home or a placebo.
The study continues in a blinded, placebo-controlled manner to assess changes in kidney function measured by estimated glomerular filtration rate. Vera Therapeutics expects those results in the third quarter of 2026.
Vera Therapeutics Technical Analysis
The stock climbed nearly 9% on Tuesday, even as the broader market traded lower. The Nasdaq fell 1.36%, while the S&P 500 slipped 0.30%.
The stock continues to trade well above its key moving averages. It sits about 15% above its 20-day simple moving average, 20% above its 50-day average, 13% above its 100-day average and 14% above its 200-day average.
Momentum indicators also remain positive. The moving average convergence divergence (MACD) indicator is above its signal line, suggesting buying momentum remains intact.
However, one longer-term technical signal still bears watching. The 50-day moving average remains below the 200-day moving average following a death cross in June. Traders often view that as a sign that the longer-term trend is still recovering.
The next resistance level is near $45.50. Support is around $38.
VERA Stock Price Activity: Vera Therapeutics shares were up 8.97% at $43.73 at the time of publication on Tuesday, according to market data.
