Vera Therapeutics Inc. (VERA), a late clinical-stage biotechnology company developing treatments for immunological diseases, has a couple of clinical trial catalysts and regulatory milestones to watch in the coming months.
The company's lead product candidate is Atacicept, a fusion protein self-administered at home as a subcutaneous once-weekly injection, which is under regulatory review in the U.S. for the proposed treatment of adults with immunoglobulin A nephropathy (IgAN). The FDA decision is due on July 7, 2026. If approved, the company expects to launch Atacicept in mid-2026.
Atacicept is also being studied in a phase 2 trial, dubbed PIONEER, and in a phase 3 trial, dubbed ORIGIN 3.
-- PIONEER is a phase 2 basket trial evaluating Atacicept in expanded IgAN populations, and other autoimmune kidney diseases like pMN (Primary Membranous Nephropathy) and MCD/FSGS (Minimal Change Disease/Focal Segmental Glomerulosclerosis in participants ages 10 and above.
Initial results from the PIONEER trial are expected in 1H 2026.
-- ORIGIN 3 is a pivotal phase 3 study evaluating the effect of Atacicept vs placebo on proteinuria and renal function preservation in IgAN.
The company expects to report the two-year eGFR data from the ORIGIN 3 trial in 2027.
For the year ended December 31, 2025, Vera Therapeutics' net loss widened to $299.6 million, or $4.66 per share, from $152.1 million, or $2.75 per share, in 2024.
The company held $714.6 million in cash, cash equivalents, and marketable securities as of December 31, 2025.
VERA closed Wednesday's trading at $41.68, down 1.63%.
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