Vera Therapeutics Expects FDA Approval for Atacicept in Q4 2025, Commercial Launch in 2026

Vera Therapeutics reported Q2 EPS of $1.20, beating consensus of 62 cents. The company announced exciting clinical results from its ORIGIN 3 trial for atacicept in IgAN patients, with plans to submit a BLA to the FDA for accelerated approval in Q4 2025 and a commercial launch in 2026. Atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor.

Vera Therapeutics, Inc. (NASDAQ: VERA) reported its second-quarter 2025 financial results, with a net loss of $76.5 million, or $1.20 per diluted share, missing analyst expectations [1]. The company also announced positive clinical results from its ORIGIN 3 trial for atacicept, a dual BAFF/APRIL inhibitor, in patients with IgA Nephropathy (IgAN).

The ORIGIN 3 trial demonstrated a 46% reduction in proteinuria for atacicept-treated patients, meeting the primary endpoint with a statistically significant 42% reduction compared to placebo (p0.0001) [2]. Vera plans to submit a Biologics License Application (BLA) for atacicept to the U.S. FDA in Q4 2025, with an expected commercial launch in 2026. The company anticipates presenting the full 36-week results from the ORIGIN 3 trial at a medical congress in Q4 2025.

Vera also initiated the PIONEER trial to evaluate atacicept in expanded IgAN populations, including anti-PLA2R positive primary membranous nephropathy (pMN), and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients [2]. The company aims to complete the pivotal ORIGIN 3 study in 2027.

Vera's financial results for the quarter ended June 30, 2025, also included a net cash used in operating activities of $109.2 million, compared to $58.6 million for the same period last year. The company reported $556.8 million in cash, cash equivalents, and marketable securities as of June 30, 2025 [2].

Analysts maintain a "buy" rating on Vera Therapeutics, with 12 "strong buy" or "buy" recommendations, 2 "hold" recommendations, and no "sell" or "strong sell" recommendations [1]. The median 12-month price target for Vera Therapeutics is $67.50, about 69.7% above its August 4 closing price of $20.45 [1].

References:
[1] https://www.tradingview.com/news/reuters.com,2025:newsml_PLX3282BB:0-vera-therapeutics-q2-net-loss-widens/
[2] https://www.morningstar.com/news/globe-newswire/9506160/vera-therapeutics-provides-business-update-and-reports-second-quarter-2025-financial-results