Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy

Rhea-AI Summary

Vera Therapeutics (Nasdaq: VERA) received FDA accelerated approval for TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy at risk for progression. TRUTAKNA is a once-weekly 150 mg subcutaneous autoinjector that binds both BAFF and APRIL, targeting key immunological drivers of IgAN.

In the Phase 3 ORIGIN 3 interim analysis, TRUTAKNA achieved a 46% proteinuria reduction from baseline and 42% versus placebo at 36 weeks (p<0.0001), with generally well-tolerated safety. Continued approval may depend on confirming kidney function benefit, with eGFR results expected in Q3 2026.

Positive

• FDA accelerated approval of TRUTAKNA for adults with primary IgA nephropathy
• 46% reduction from baseline in UPCR at 36 weeks in ORIGIN 3
• 42% proteinuria reduction versus placebo (p<0.0001) at 36 weeks
• 68% reduction in galactose-deficient IgA1 as a secondary endpoint
• TRUTAKNA generally well tolerated in 428 treated and placebo patients
• Proteinuria efficacy consistent across multiple prespecified patient subgroups

Negative

• Approval based solely on proteinuria reduction, not long-term kidney outcomes
• Continued approval may depend on confirming clinical benefit in ORIGIN 3
• Higher rates of infections with TRUTAKNA versus placebo (32% vs 28%)
• Higher local administration reactions with TRUTAKNA versus placebo (30% vs 5%)

News Market Reaction – VERA

+7.05%

11 alerts

+7.05% Session close to close

+3.8% Peak Tracked

-4.1% Trough Tracked

$2.96B Market Cap

0.9x Rel. Volume

In the Jul 7 session, VERA gained 7.05%, reflecting a notable positive market reaction. Argus tracked a peak move of +3.8% during that session. Argus tracked a trough of -4.1% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +7.0% in the session following this news. A sharp upside move would track with the s...

Analysis

The stock moved +7.0% in the session following this news. A sharp upside move would track with the strong ORIGIN 3 data, including a 42% proteinuria reduction versus placebo and tolerability. Past reactions to key updates were mixed, while elevated short positioning and recent insider net selling could add volatility.

Key Figures

TRUTAKNA dose: 150 mg once weekly Proteinuria reduction: 46% reduction Proteinuria vs placebo: 42% reduction (p<0.0001) +5 more

8 metrics

TRUTAKNA dose 150 mg once weekly Self-administered subcutaneous injection at home

Proteinuria reduction 46% reduction From baseline at 36 weeks in TRUTAKNA-treated participants

Proteinuria vs placebo 42% reduction (p<0.0001) Compared to placebo at 36 weeks in ORIGIN 3

Interim analysis population 203 participants Primary 36-week UPCR endpoint in ORIGIN 3

Gd-IgA1 reduction 68% reduction Secondary endpoint in ORIGIN 3, observational without multiplicity adjustment

Safety population 428 patients Received at least one dose of TRUTAKNA or placebo in ORIGIN 3

Infections incidence 32% vs 28% Most common adverse reaction in TRUTAKNA vs placebo groups

US IgAN patients Approximately 160,000 Estimated adults impacted by IgA nephropathy in the U.S.

Historical Context

5 past events · Latest: Jun 05 (Neutral)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 05	inducement grants	Neutral	-0.2%	Equity inducement stock options and RSUs granted to new employees.
Jun 02	clinical trial update	Positive	-7.9%	FDA alignment on earlier ORIGIN Phase 3 eGFR analysis for atacicept.
May 08	inducement grants	Neutral	+1.2%	Stock option and RSU inducement awards under 2024 Inducement Plan.
May 07	earnings report	Neutral	-1.9%	Q1 2026 results plus Priority Review and PDUFA timing for atacicept.
May 04	conference participation	Neutral	+0.9%	Participation in Bank of America 2026 Health Care Conference with webcast.

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

Pattern Detected

Recent Vera headlines have drawn relatively modest and mixed single-day reactions, even around regulatory and clinical milestones.

Key Terms

b-cell activating factor, april, proteinuria, estimated glomerular filtration rate, +2 more

6 terms

b-cell activating factor medical

"therapy that binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand"

B‑cell activating factor is a naturally occurring protein that helps B cells — the immune cells that make antibodies — grow, survive and produce antibodies; think of it like a fertilizer for a specific plant in the immune system garden. It matters to investors because drugs or diagnostic tests that block or measure this protein are used to treat or track autoimmune diseases and some cancers, so clinical data or regulatory news about BAFF-targeting approaches can materially affect biotech and pharmaceutical valuations.

april medical

"binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL)"

April is the fourth month of the year and the first month of the second calendar quarter for most businesses. For investors, April often marks the transition from one reporting period to the next—companies close their first-quarter books and many issue quarterly results or guidance—so it can signal fresh information that affects stock prices, much like a school report card that helps parents reassess progress and expectations.

proteinuria medical

"accelerated approval to reduce proteinuria in adults with primary IgAN"

Proteinuria is when abnormal amounts of protein are found in a person's urine. It can be a sign that the kidneys aren't working properly, since healthy kidneys usually prevent most proteins from passing into urine. Detecting proteinuria helps doctors identify and monitor kidney problems early.

estimated glomerular filtration rate medical

"evaluate change in kidney function as measured by estimated glomerular filtration rate (eGFR)"

Estimated glomerular filtration rate (eGFR) is a calculated measure of how well the kidneys are cleaning waste and excess fluid from the blood, based on blood test results and basic patient information. Think of it as a speedometer for kidney function: a lower number means the kidneys are working more slowly. Investors care because eGFR influences drug dosing, trial eligibility, safety profiles, and the size of patient populations for therapies targeting kidney or related diseases.

urine-protein-to-creatinine-ratio medical

"primary efficacy endpoint ... change in 24-hour urine-protein-to-creatinine-ratio (UPCR)"

Urine-protein-to-creatinine ratio is a lab measurement from a single urine sample that compares the amount of protein to the amount of creatinine to estimate daily protein loss in the urine. For investors, it serves as a widely used clinical marker of kidney damage or drug-related kidney effects—like a quick dashboard gauge showing whether a treatment or condition is causing the kidneys to leak protein, which can influence clinical trial results, safety assessments, and regulatory outcomes.

galactose-deficient iga1 medical

"experienced a 68% reduction in galactose-deficient IgA1 (Gd-IgA1), a secondary endpoint"

A form of the antibody IgA1 that lacks a normal sugar unit called galactose on its structure; this alteration changes how the antibody behaves and can make the immune system treat it as abnormal. It matters to investors because galactose-deficient IgA1 is a key biological marker and suspected cause in certain kidney disorders, so tests or drugs aimed at it can drive clinical development, regulatory milestones, and company valuation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• TRUTAKNA is the first and only available therapy that binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), addressing the immunological drivers at the source of IgA nephropathy (IgAN).^1,2
• The TRUTAKNA dose is 150 mg injected subcutaneously once weekly, self-administered via an autoinjector by patients at home.¹
• Investor webcast is scheduled for July 7 at 4:30 pm EDT.

A Media Snippet accompanying this announcement is available by clicking on this link.

BRISBANE, Calif., July 07, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted TRUTAKNA (atacicept-vymj) accelerated approval to reduce proteinuria in adults with primary IgAN at risk for disease progression. In a prespecified interim analysis of the ongoing ORIGIN 3 trial, participants treated with TRUTAKNA achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo (p<0.0001) at 36 weeks. In this registrational program, TRUTAKNA was generally well tolerated. The most common adverse reactions were infections and local administration reactions.¹

IgAN is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide.^2,3 Approximately 160,000 patients are estimated to be impacted by IgAN in the U.S. Globally, approximately 2.5 adults per 100,000 are diagnosed with IgAN each year, most often between 30 and 40 years of age.^4,5

“The approval of TRUTAKNA as the first and only BAFF and APRIL inhibitor for IgAN marks an important milestone and we believe it has the potential to meaningfully transform the treatment landscape. We believe TRUTAKNA offers a novel approach to addressing this serious disease and has the potential to advance care for patients with this significant unmet medical need,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We are grateful to the patients, investigators, study teams and regulators whose efforts made this achievement possible.”

“I frequently hear from IgAN patients who are uncertain about what this disease may mean for their future, reflecting the historic high risk of poor outcomes with standard therapies,” said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and a principal investigator in the ORIGIN clinical program. “TRUTAKNA offers patients and their nephrologists an exciting new treatment advancement that inhibits both BAFF and APRIL, the two key cytokines that act on B cells, which are at the source of IgAN pathophysiology.”

“We started the IgAN Foundation 22 years ago to create a community and encourage the development of innovative therapies. People and families living with this disease know how urgently we need more treatment options,” said Bonnie Schneider, Director and Co-Founder of the IgAN Foundation. “We value our long-standing relationship with Vera Therapeutics and our shared commitment to making the patient experience central to clinical research. The approval of TRUTAKNA provides great hope for patients and the IgAN community.”

This accelerated approval is 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 the ongoing ORIGIN 3 trial, which continues in a placebo-controlled, blinded manner to evaluate change in kidney function as measured by estimated glomerular filtration rate (eGFR), with results anticipated in Q3 2026.

Investor Webcast on July 7 at 4:30 pm EDT

The investor webcast discussing the accelerated approval of TRUTAKNA will be on July 6 at 4:30 pm EDT. To register for the webcast, click here.

A replay of the webcast will be available on the Investors & Media page of the Company’s website following the event. 

Data Supporting Approval

ORIGIN 3 (NCT04716231) is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of adults with IgA nephropathy. Participants were randomized 1:1 to TRUTAKNA 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint of the prespecified 36-week interim analysis was the change in 24-hour urine-protein-to-creatinine-ratio (UPCR) compared to placebo in the first 203 participants who had received at least 1 dose of TRUTAKNA or placebo. Participants treated with TRUTAKNA achieved a 46% reduction from baseline in UPCR, with a statistically significant and clinically meaningful 42% reduction compared to placebo (p<0.0001) at 36 weeks. Proteinuria efficacy was consistent across prespecified subgroups of age, sex, race, region, baseline proteinuria, baseline eGFR, and baseline SGLT2i use. Participants who received TRUTAKNA also experienced a 68% reduction in galactose-deficient IgA1 (Gd-IgA1), a secondary endpoint with observational results due to the absence of multiplicity adjustment.¹

In ORIGIN 3, the safety of TRUTAKNA was assessed in 428 patients who had received at least 1 dose of TRUTAKNA or placebo. TRUTAKNA was generally well tolerated. 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%).¹ No serious, severe or opportunistic infections, or hypogammaglobulinemia, were observed in TRUTAKNA-treated patients.⁶ Most adverse reactions observed in the TRUTAKNA group were mild or moderate in severity and resolved without treatment interruption or discontinuation. There were no clinically significant effects of anti-drug antibodies on the pharmacokinetics, pharmacodynamics, safety or effectiveness of TRUTAKNA over the 36-week treatment period.¹ Please see below for Important Safety Information.

About IgAN

IgAN is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide.^2,3 Approximately 2.5 adults per 100,000 worldwide are diagnosed with IgAN each year, most often between 30 and 40 years of age.^4,5 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.³ Current clinical guidelines recommend reducing the rate of kidney function decline to the physiological state (<1 mL/min/year for most adults) as a central treatment goal in IgAN, and proteinuria reduction is recognized as a surrogate marker of reduced risk of kidney function decline.⁷

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 TRUTAKNA (atacicept-vymj) injection

TRUTAKNA, a BAFF and 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.¹ These cytokines activate B cells to produce the autoantigen Gd-IgA1 and its autoantibodies, forming immune complexes that deposit in the kidneys and cause inflammation and progressive damage.² TRUTAKNA is a self-administered autoinjector dosed 150 mg once weekly.¹

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 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 number of patients impacted by IgAN in the U.S. and globally; the potential for continued approval of atacicept in IgAN; the potential for TRUTAKNA to meaningfully transform the treatment landscape; the ability of TRUTAKNA to offer a novel approach to addressing IgAN and its potential to advance care for IgAN patients; the potential for TRUTAKNA to provide hope for patients and the IgAN community; the expected results and timing of the results of the ORIGIN 3 eGFR analysis; 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, 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. TRUTAKNA™ [Prescribing Information]. Brisbane, CA: Vera Therapeutics, Inc; July 2026.

2. 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

3. 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

4. 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

5. 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

6. 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

7. Floege J, Barratt J, Cook HT, et al. Executive summary of the KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025;108(4):548-554. doi:10.1016/j.kint.2025.04.003

For more information, please contact:

Investor Contact:
Joyce Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com

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

FAQ

What did Vera Therapeutics (VERA) announce about TRUTAKNA on July 7, 2026?

Vera Therapeutics announced FDA accelerated approval of TRUTAKNA to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. According to Vera Therapeutics, this is the first available therapy that binds both BAFF and APRIL, directly targeting IgAN’s immunological drivers.

What are the key ORIGIN 3 Phase 3 results supporting TRUTAKNA for VERA investors?

TRUTAKNA achieved a 46% reduction from baseline in 24-hour UPCR and a 42% reduction versus placebo at 36 weeks (p<0.0001). According to Vera Therapeutics, efficacy was consistent across prespecified subgroups, and 428 patients contributed to the safety evaluation in this registrational program.

How is TRUTAKNA for IgA nephropathy dosed and administered for Vera Therapeutics patients?

TRUTAKNA is dosed at 150 mg once weekly, given as a subcutaneous injection via an autoinjector that patients can self-administer at home. According to Vera Therapeutics, this regimen is designed to provide convenient, ongoing inhibition of BAFF and APRIL for IgAN management.

What safety profile did TRUTAKNA show in the ORIGIN 3 trial for IgAN?

TRUTAKNA was generally well tolerated, with infections (32% vs 28% placebo) and local administration reactions (30% vs 5%) as the most common adverse reactions. According to Vera Therapeutics, no serious, severe, opportunistic infections or hypogammaglobulinemia were observed over 36 weeks.

What does FDA accelerated approval of TRUTAKNA mean for long-term kidney outcomes in IgAN?

The accelerated approval is based on proteinuria reduction and does not yet establish long-term kidney function benefit. According to Vera Therapeutics, continued approval may depend on confirming clinical benefit from eGFR outcomes in the ongoing ORIGIN 3 trial, with results expected in Q3 2026.

How large is the potential IgA nephropathy patient population for TRUTAKNA and VERA?

Approximately 160,000 patients in the United States are estimated to be impacted by IgAN. According to Vera Therapeutics, globally about 2.5 adults per 100,000 are diagnosed with IgAN annually, most often between 30 and 40 years of age, underscoring significant unmet need.

When is the Vera Therapeutics (VERA) investor webcast about TRUTAKNA’s FDA approval?

An investor webcast discussing the accelerated approval of TRUTAKNA is scheduled for July 7 at 4:30 pm EDT. According to Vera Therapeutics, a replay will be available on the company’s Investors & Media webpage following the live event for shareholders and analysts.