The U.S. Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Vera Therapeutics Inc.'s 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 company's stock climbed nearly 9%. The approval is based on the therapy's ability to reduce proteinuria, though 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.

The Biologics License Application (BLA) submission was supported by a prespecified interim analysis from the ongoing Phase 3 ORIGIN 3 trial involving the first 203 participants. 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.

ORIGIN 3 Trial and Future Plans

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 (eGFR). Vera Therapeutics expects those results in the third quarter of 2026. Pending these results, the company plans to submit a supplemental Biologics License Application (sBLA) for full approval in the fourth quarter of 2026.

Competitive Landscape

Novartis AG remains a key competitor in the IgAN treatment space. In April 2025, the FDA granted accelerated approval to Novartis's Vanrafia (atrasentan) for the reduction of proteinuria in adults with IgAN. In February, Novartis shared final results from the Phase 3 ALIGN study, which supported a slowing decline in kidney function in adults with IgAN treated with Vanrafia. Following the trial data, Novartis plans to submit for traditional approval in 2026.

Key Trial Data for Trutakna

Vera Therapeutics shares were up 8.97% at $43.73 at the time of publication on Tuesday.

Vera Therapeutics, Inc. granted inducement awards to ten new employees on June 2, 2026, consisting of non-qualified stock options to purchase 28,800 shares of Class A common stock and restricted stock units (RSUs) underlying 14,150 shares of Class A common stock. The awards were approved by the Compensation Committee of the Board of Directors as an employment inducement under the Vera Therapeutics, Inc. 2024 Inducement Plan and in accordance with Nasdaq Listing Rule 5635(c)(4).

Each stock option granted on June 2, 2026, carries an exercise price of $31.26 per share, which equals the company's closing trading price on that date. The options will vest over four years, with 25% of the underlying shares vesting on the first anniversary of the applicable vesting commencement date and the remainder vesting monthly over the subsequent 36 months, contingent on continued service.

The RSU awards will also vest over four years, with 25% of the underlying shares vesting on each anniversary of either May 20 or August 20, 2026, depending on the new employee's start date. All awards are subject to the terms of the Inducement Plan and the applicable award agreements.

Award Details

The grants are intended as material inducements for the new employees to join the company. Vera Therapeutics focuses on developing treatments for serious immunological diseases, with its lead product candidate being atacicept.