Shares of Vera Therapeutics, Inc. (VERA) surged 6.24% in after-hours trading on Friday, following the company's announcement of a significant milestone in its drug development pipeline. The clinical-stage biotechnology firm has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, atacicept, targeting the treatment of adults with immunoglobulin A nephropathy (IgAN).

The BLA submission is supported by impressive data from the ORIGIN Phase 3 trial, which met its primary endpoint with a 46% reduction in proteinuria from baseline. Atacicept demonstrated a statistically significant and clinically meaningful 42% reduction in proteinuria compared to placebo at week 36 (p<0.0001). The drug's safety profile appears favorable and comparable to placebo across the ORIGIN program.

Investors are likely encouraged by atacicept's potential to become the first B cell modulator targeting both BAFF and APRIL for IgAN, a serious and progressive autoimmune disease of the kidney. The FDA has already granted Breakthrough Therapy Designation to atacicept, reflecting its potential to offer substantial improvement over existing therapies. With possible FDA approval on the horizon in 2026, Vera Therapeutics is positioning itself as a frontrunner in addressing the high unmet need for new disease-modifying treatments in IgAN.