Vera Therapeutics Surges Then Reverses After TRUTAKNA Phase 3 Trial Hits All Endpoints

Vera Therapeutics shares jumped as much as 14.8% in premarket trading on September 15 before reversing course to trade down about 2% at $33.34 by midday, after the company announced that TRUTAKNA (atacicept-vymj) met all primary and secondary endpoints in the final 104-week efficacy analysis of its Phase 3 ORIGIN 3 trial for IgA nephropathy. The drug, a dual BAFF/APRIL inhibitor, stabilized eGFR and prevented kidney disease progression through two full years in the study. The results represent a key step toward securing full FDA approval for the injectable kidney therapy, which already carries priority review status.

The FDA has aligned on an accelerated review path for atacicept, with the company targeting a regulatory filing in the fourth quarter of 2026. Prior data from the ORIGIN trial had shown a 46% reduction in proteinuria compared to baseline. Despite the clinical milestone and regulatory clarity, the stock remains down roughly 40% year to date, reflecting lingering investor skepticism about execution on the development and commercialization timeline.

Raymond James maintained its Strong Buy rating on the stock following the data release, and TD Cowen reiterated its Buy. Seeking Alpha kept a Hold rating, citing caution despite the positive readout. The intraday reversal from a double-digit premarket gain to a modest loss underscored that enthusiasm around the trial results was tempered by broader concerns about the company's path forward.