Vera Therapeutics Announces Positive ORIGIN 3 Final Efficacy Analysis of TRUTAKNA™ (atacicept-vymj) in IgA Nephropathy Presented at ASN Kidney Week 2026 and Published in the New England Journal of Medicine

Vera plans to seek full FDA approval after the trial met its kidney-function and disease-progression endpoints.

Rhea-AI Summary

Vera Therapeutics (VERA) announced that TRUTAKNA achieved statistical significance across all prespecified endpoints in the ORIGIN 3 final efficacy analysis. The trial studied adults with primary IgA nephropathy at risk for disease progression. Results included changes in estimated kidney filtration rate, its annualized slope, and reduced risk of composite kidney disease progression events. The primary endpoint of reduced urine protein at 36 weeks was also met.

Adverse events occurred in 75% of TRUTAKNA patients versus 78% on placebo; serious adverse events occurred in 7% versus 15%. Vera plans a supplemental biologics license application in Q4 2026, with potential full FDA approval in 2027. TRUTAKNA currently has accelerated approval to reduce urine protein; long-term slowing of kidney function decline has not been established. Results were presented at ASN Kidney Week 2026 and published in The New England Journal of Medicine.

9 points · 1 major

PositiveiHow this balance works

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointORIGIN 3 met its primary endpoint of statistically significant proteinuria reduction at 36 weeks.
• Moderate pointKidney filtration rate change and annualized slope achieved statistical significance in the final efficacy analysis.
• Moderate pointComposite kidney disease progression events showed a statistically significant risk reduction.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Vera plans a supplemental application in Q4 2026, targeting potential full FDA approval in 2027.
• Minor pointGalactose-deficient IgA1 and hematuria, or blood in urine, showed statistically significant reductions.

4 minor points

• Minor pointAdverse events occurred in 75% versus 78% on placebo; serious adverse events were 7% versus 15%.
• Minor pointInfection rates were 51.4% versus 52.3% on placebo, with no clinically relevant hypogammaglobulinemia or opportunistic infections observed.
• Minor pointDeaths numbered zero on TRUTAKNA versus one on placebo.
• Minor pointAnti-drug antibodies showed no clinically meaningful effect on efficacy or overall safety.

Negative

• Moderate pointCurrent accelerated approval may depend on confirmatory clinical benefit; long-term slowing of kidney function decline remains unestablished.

Key Figures

Primary endpoint timing: 36 weeks Adverse events: 75% (160/214) vs. 78% (167/214) Serious adverse events: 7% vs. 15% +4 more

Primary endpoint timing

36 weeks

Statistically significant proteinuria reduction

Adverse events

75% (160/214) vs. 78% (167/214)

TRUTAKNA vs. placebo

Serious adverse events

7% vs. 15%

TRUTAKNA vs. placebo

Infection rates

51.4% vs. 52.3%

TRUTAKNA vs. placebo

Deaths

0 vs. 1

TRUTAKNA vs. placebo

Supplemental BLA submission

Q4 2026

Company plans to submit to the U.S. FDA

Full approval timing

2027

Potential FDA full approval expected

Historical Context

1 past event · Latest: Sep 15

1 event

1. Sep 15

   ORIGIN 3 results

   24h Move

   -1.1%

   Reported ORIGIN 3 efficacy results, including kidney-function stabilization and reduced progression versus placebo.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

hypogammaglobulinemia, anti-drug antibodies, accelerated approval

3 terms

hypogammaglobulinemia medical

"no clinically relevant hypogammaglobulinemia or opportunistic infections were observed"

A condition in which a person has abnormally low levels of antibodies in the blood, leaving the immune system less able to fight infections; think of it as having too few security guards on duty to spot and stop intruders. For investors, it matters because the condition affects demand for treatments, outcomes and safety in clinical trials, regulatory scrutiny, and healthcare costs—factors that influence revenue and risk for companies in diagnostics, therapeutics, and care services.

anti-drug antibodies medical

"No clinically meaningful effect of anti-drug antibodies on efficacy"

Anti-drug antibodies are immune system proteins that form in patients in response to a biological therapy, such as a therapeutic protein or antibody, and can bind to the medicine. They matter to investors because they can reduce or eliminate a drug’s effectiveness, create safety problems, force higher dosing or additional testing, and influence regulatory approval and commercial success — like delivery guards accidentally intercepting and stopping a needed package.

accelerated approval regulatory

"This indication is approved under accelerated approval based on reduction of proteinuria"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

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• TRUTAKNA, the first and only FDA-approved BAFF and APRIL inhibitor, achieved statistical significance in all prespecified endpoints, including eGFR change from baseline and annualized slope, and risk reduction in composite kidney disease progression events.
• Favorable safety profile, and generally comparable to placebo.
• Plan to submit supplemental BLA to the U.S. FDA in Q4 2026 for full approval expected in 2027.
• Investor webcast is scheduled for October 22 at 4:30 pm EDT.

BRISBANE, Calif., Oct. 22, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that the final efficacy analysis for the ORIGIN 3 trial of TRUTAKNA in adults with primary IgA nephropathy (IgAN) at risk for disease progression was presented as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2026 and simultaneously published in The New England Journal of Medicine.

ORIGIN 3 met the primary endpoint of statistically significant proteinuria reduction at 36 weeks. In the final efficacy analysis, TRUTAKNA achieved statistical significance in all prespecified endpoints.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6f52e3a8-5843-4d89-a51b-a1344e2a52b3

TRUTAKNA also achieved statistically significant reductions in urine-protein to creatinine ratio, galactose-deficient IgA1, and hematuria. TRUTAKNA was well tolerated with a favorable safety profile generally comparable to placebo, consistent with previous safety data from the ORIGIN program.¹ Adverse events occurred in 160/214 patients (75%) on TRUTAKNA and 167/214 on placebo (78%). The rate of serious adverse events in the TRUTAKNA group was 7% compared with 15% in the placebo group. Infection rates were similar between TRUTAKNA (51.4%) and placebo groups (52.3%), and no clinically relevant hypogammaglobulinemia or opportunistic infections were observed. There was 1 death in the placebo group and no deaths in the TRUTAKNA group. No clinically meaningful effect of anti-drug antibodies on efficacy or overall safety was identified.

“I have spent my career caring for people with IgAN, and for most of that time, our conversations were about the limited treatment options," said Jonathan Barratt, PhD, FRCP, Mayer Professor of Renal Medicine, University of Leicester. "The ORIGIN 3 final efficacy results have the potential to change those conversations. In the study, TRUTAKNA achieved a physiologic rate of eGFR loss compared to the pathologic rate observed with placebo and significantly reduced the risk of composite kidney disease progression events, reflecting the potential for disease modification and kidney protection in IgAN. These results, combined with a safety profile comparable to placebo, represent a meaningful advance for patients."

“ORIGIN 3 represents an important innovation in IgAN clinical development through our alignment with the FDA on an earlier final efficacy analysis. As a physician, I value the ability to offer patients randomized to placebo an earlier opportunity to transition to open-label active treatment, while generating a robust dataset. With the strength of the clinical data package, TRUTAKNA has the potential to transform the treatment landscape,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We plan to submit the supplemental BLA in the fourth quarter of this year, and we look forward to potential FDA full approval of TRUTAKNA in 2027. We reiterate our gratitude to the patients, investigators, employees, and collaborators who have helped us to deliver TRUTAKNA to patients in need.”

The Company will host an investor call and webcast to discuss the trial results at 4:30 PM EST on October 22. To register, click here.

The live webcast will be available on the Company’s Investor Calendar, with the recording and presentation available immediately following the event.

Indication

TRUTAKNA (atacicept-vymj) is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression.

This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether TRUTAKNA slows kidney function decline over the long-term in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Important Safety Information

Contraindications: TRUTAKNA is contraindicated in patients with serious hypersensitivity to atacicept-vymj or any excipients of TRUTAKNA.

Warnings and Precautions

Immunosuppression and Increased Risk of Infections: TRUTAKNA suppresses the immune system by reducing antibody production, which may increase the risk of infections. Patients with chronic infection or recurring infections may have an increased risk of serious infection. In clinical trials, infections were reported in 32% of TRUTAKNA patients compared with 28% of placebo patients.

Before initiating TRUTAKNA, assess patients for active infections. Delay TRUTAKNA administration in patients with active infection until the infection resolves or is adequately treated. Monitor patients for signs and symptoms of infection during treatment with TRUTAKNA. If a serious infection develops, consider interrupting TRUTAKNA until the infection is controlled.

The concomitant use of TRUTAKNA and other immune-modulating therapies has not been evaluated. Concomitant use of TRUTAKNA with drugs that affect the immune system, including systemic corticosteroids, may increase the risk of infection.

Immunosuppression and Immunization Risk: TRUTAKNA may interfere with the immune response to vaccines and increase the risk of infection from live vaccines. Prior to initiating treatment with TRUTAKNA, complete all age-appropriate immunizations. Live vaccines are not recommended within 30 days prior to initiation or during treatment with TRUTAKNA as safety of coadministration has not been established.

Adverse Reactions: The most common adverse reactions (≥5%) in patients treated with TRUTAKNA and placebo, respectively, were infections (32% vs 28%) and local administration reactions (30% vs 5%). The most common infection was upper respiratory tract infection (12% vs 9%), and the most common local administration reactions were injection site reaction (19% vs 2%) and injection site erythema (6% vs 1%).

Use in Specific Populations

Pregnancy: Available data on TRUTAKNA used in pregnant women exposed during clinical trials are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Based on the mechanism of action, TRUTAKNA may cause immunosuppression in the in utero-exposed infant. Consider the potential clinical impact of TRUTAKNA exposure in infants exposed in utero. Pregnant women exposed to TRUTAKNA, or their healthcare provider, should report TRUTAKNA exposure by calling 1-833-633-8372.

Pediatric Use: The safety and effectiveness of TRUTAKNA in pediatric patients have not been established.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Vera Therapeutics at 1-833-MED-VERA or medinfo@veratx.com.

Please see full Prescribing Information for additional Important Safety Information.

About TRUTAKNA (atacicept-vymj)

TRUTAKNA, a B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) inhibitor, is a soluble recombinant fusion protein containing the human transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines BAFF and APRIL.² BAFF and APRIL are key cytokines that activate B cells and drive IgAN pathophysiology. In IgAN, activated B cells produce both the antigen and associated antibodies that result in the production of damaging IgA immune complexes. The overlapping roles of BAFF and APRIL in activating B cells support the potential for TRUTAKNA as a disease-modifying therapy.³ TRUTAKNA is self-administered as an at-home, small-volume (1 ml), 150 mg once-weekly autoinjector.

TRUTAKNA TRU SUPPORT™ Patient Support Program

We are dedicated to ensuring that eligible IgAN patients can access the first approved therapy that targets both BAFF and APRIL. TRUTAKNA TRU SUPPORT, our patient support program, offers insurance coverage assistance, financial assistance options for eligible patients, and educational resources designed to support patient access and care. Eligible commercially insured patients may pay as little as $0 out of pocket through our copay assistance program. More information will be available on www.veratx.com.

About IgAN

IgAN is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide.^3,4 Approximately 2.5 adults per 100,000 worldwide are diagnosed with IgAN each year, most often between 30 and 40 years of age.^5,6 Over time, IgAN can lead to irreversible kidney damage and may ultimately require dialysis or kidney transplantation. At least 50% of patients may progress to kidney failure or death within 10 to 20 years of diagnosis.⁴

About Vera Therapeutics

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNA (atacicept-vymj), a BAFF and APRIL inhibitor indicated to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit www.veratx.com.

Forward-looking Statements

Statements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the timing of the supplemental BLA submission to the FDA as well as full approval of TRUTAKNA by the FDA; the potential for the FDA to grant full approval to TRUTAKNA; the potential for TRUTAKNA to achieve results that reflect disease modification and kidney protection in IgAN; the potential for TRUTAKNA to represent a meaningful advance for patients; the ability for ORIGIN 3 to represent an important innovation in IgAN clinical development; the ability for TRUTAKNA to transform the treatment landscape; the potential for TRUTAKNA to be a disease-modifying therapy; and the plans, commitments, aspirations and goals under the caption “About Vera Therapeutics”. Words such as “anticipate,” “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, risks related to commercial launch, market acceptance, and payer coverage, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera Therapeutics’ business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera Therapeutics' filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

References

1. Lafayette R, Barbour SJ, Brenner RM, et al. A Phase 3 Trial of Atacicept in Patients with IgA Nephropathy. N Engl J Med. 2026;394(7):647-657. doi:10.1056/NEJMoa2510198.

2. TRUTAKNA™ [Prescribing Information]. Brisbane, CA: Vera Therapeutics, Inc; July 2026

3. Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and APRIL in IgA nephropathy: pathogenic mechanisms and targeted therapies. Front Nephrol. 2024;3:1346769. Published 2024 Feb 1. doi:10.3389/fneph.2023.1346769

4. Pitcher D, Braddon F, Hendry B, et al. Long-Term Outcomes in IgA Nephropathy. Clin J Am Soc Nephrol. 2023;18(6):727-738. doi:10.2215/CJN.0000000000000135

5. McGrogan A, Franssen CF, de Vries CS. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrol Dial Transplant. 2011;26(2):414-430. doi:10.1093/ndt/gfq665

6. Jarrick S, Lundberg S, Welander A, et al. Mortality in IgA Nephropathy: A Nationwide Population-Based Cohort Study. J Am Soc Nephrol. 2019;30(5):866-876. doi:10.1681/ASN.2018101017

For more information, please contact:
Investor Contact:
Joshua Qin
Vera Therapeutics
650-360-6978
ir@veratx.com

Media Contact:
Debra Charlesworth
Vera Therapeutics
415-854-8051
corporatecommunications@veratx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Vera Therapeutics report from the TRUTAKNA ORIGIN 3 final efficacy analysis?

TRUTAKNA achieved statistical significance in all prespecified endpoints, including kidney filtration rate change, annualized slope, and reduced risk of composite kidney disease progression events. The trial also met its primary endpoint of reduced urine protein at 36 weeks in adults with primary IgA nephropathy at risk for disease progression.

When does Vera Therapeutics plan to seek full FDA approval for TRUTAKNA?

Vera plans to submit a supplemental biologics license application in Q4 2026, with potential full FDA approval in 2027. TRUTAKNA currently has accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.