Vera Therapeutics Provides Business Update and Reports Third Quarter 2026 Financial Results
Nine-month operating cash use rose to $305.9 million as Vera invested in the commercial launch of TRUTAKNA.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Vera Therapeutics (Nasdaq: VERA) reported third-quarter 2026 net product revenue of $10.3 million following the U.S. launch of TRUTAKNA. The drug received accelerated FDA approval on July 7 to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. Approximately 700 Patient Start Forms have been received since launch.
ORIGIN 3 met all prespecified endpoints, with a 76% reduction in composite kidney disease progression risk versus placebo through two years. Vera submitted its application for full approval on November 3 and expects potential approval in mid-2027, subject to FDA review. Quarterly net loss widened to $93.7 million from $80.3 million a year earlier. Cash, cash equivalents and marketable securities totaled $384.0 million at September 30; an October debt draw added $75 million. Vera plans a European marketing application in Q1 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointFDA accelerated approval on July 7, 2026 enabled TRUTAKNA’s U.S. launch for eligible adults with primary IgAN.
- Major pointORIGIN 3 met all prespecified endpoints, including kidney filtration measures and composite kidney disease progression.
- Moderate pointTRUTAKNA net revenue reached $10.3 million in Q3 2026, versus no product revenue a year earlier.
- Moderate pointFull-approval application submitted November 3, 2026, based on ORIGIN 3 final efficacy results.
- Moderate pointQ3 research and development expense fell to $41.3 million from $56.5 million a year earlier.
- Moderate pointOctober debt draw provided $75 million, bringing September 30 liquidity to $459 million on a pro forma basis. 3.3% of market cap
7 minor points
- Minor pointApproximately 700 Patient Start Forms have been received since TRUTAKNA’s launch.
- Minor pointComposite kidney disease progression risk fell 76% versus placebo through two years in ORIGIN 3.
- Minor pointAnnual kidney filtration decline through 104 weeks was -0.6 versus -5.6 mL/min/1.73m²/year with placebo; difference 5.0, p<0.0001.
- Minor pointORIGIN 3 safety was described by Vera as favorable and generally comparable to placebo.
- Minor point. Forward-looking: it has not happened yet and may not happen.European marketing application planned for Q1 2027 for standard marketing authorisation.
- Minor pointPIONEER interim adult IgAN and primary membranous nephropathy results support continued investigation, in Vera’s assessment.
- Minor pointUp to $350 million remains available under the debt facility, subject to conditions.
Negative
- Moderate pointQ3 net loss widened to $93.7 million, or $1.30 per share, versus $80.3 million, or $1.26.
- Moderate pointNine-month operating cash use rose to $305.9 million from $171.1 million, primarily reflecting launch investment.
- Moderate pointCash, cash equivalents and marketable securities fell to $384.042 million from $714.589 million at December 31, 2025.
- Moderate pointQ3 selling, general and administrative expense rose to $61.4 million from $27.5 million, reflecting launch investment.
- Moderate pointOctober borrowing added $75 million of debt under Vera’s debt facility. 3.3% of market cap
11 minor points
- Minor pointNine-month net loss widened to $324.216 million, or $4.51 per share, versus $208.518 million, or $3.27.
- Minor pointNine-month selling, general and administrative expense rose to $152.961 million from $65.321 million a year earlier.
- Minor pointNine-month research and development expense rose to $187.344 million from $155.946 million a year earlier.
- Minor pointQ3 cost of sales was $3.296 million, versus none a year earlier.
- Minor pointQ3 operating loss widened to $95.702 million from $83.932 million a year earlier.
- Minor pointNine-month operating loss widened to $333.324 million from $221.267 million a year earlier.
- Minor pointQ3 other income, net fell to $1.991 million from $3.639 million a year earlier.
- Minor pointNine-month other income, net fell to $9.108 million from $12.749 million a year earlier.
- Minor pointRemaining debt-facility availability is conditional on satisfaction of certain conditions.
- Minor point. Forward-looking: it has not happened yet and may not happen.Potential full approval expected in mid-2027 remains subject to FDA review of the supplemental application.
- Minor pointTRUTAKNA’s label warns of immunosuppression, infection and immunization risks; trial infections occurred in 32% versus 28% with placebo.
News Explained
Vera says up to
Details
Market Reaction – VERA
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Key Figures
- Net product revenue
- $10.3 million
- Q3 2026; no product revenue in the prior-year period
- Composite kidney disease progression risk reduction
- 76%
- ORIGIN 3 versus placebo through two years
- Annualized eGFR slope
- -0.6 vs. -5.6 mL/min/1.73m²/year; treatment difference 5.0 mL/min/1.73m²/year
- ORIGIN 3 through 104 weeks; p<0.0001
- Net loss
- $93.7 million
- Q3 2026
- Net cash used in operating activities
- $305.9 million
- Nine months ended September 30, 2026
- Cash, cash equivalents, and marketable securities
- $384.0 million
- As of September 30, 2026
- sBLA submission
- November 3, 2026
- Completed submission for full approval of TRUTAKNA in adults with primary IgAN
- Potential full approval
- Mid-2027
- Expected, subject to FDA review of the sBLA
Previous Earnings Reports
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FDA granted accelerated approval for TRUTAKNA, and the U.S. launch was underway.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
accelerated approval regulatory
proteinuria medical
igan medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- TRUTAKNA® (atacicept-vymj) U.S. launch building early momentum following July 7 accelerated approval by the U.S. Food and Drug Administration (FDA) with approximately 700 Patient Start Forms (PSFs) to date and
$10.3 million of net product revenue in Q3. - ORIGIN 3 final efficacy analysis demonstrated stabilization of kidney function and a
76% reduction in risk of composite kidney disease progression versus placebo through two years; data was presented as a late-breaking oral presentation at the opening plenary session at ASN Kidney Week 2026 with a simultaneous publication in The New England Journal of Medicine. - Completed supplemental Biologics License Application (sBLA) submission to the FDA for full approval of TRUTAKNA in adults with primary IgAN.
- Management to host a live investor webcast at 4:30 p.m. ET on November 5, 2026.
BRISBANE, Calif., Nov. 05, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today reported its business highlights and financial results for the quarter ended September 30, 2026.
“We are excited by the early momentum of the TRUTAKNA launch, which exemplifies our long-standing confidence in its potential to become a foundational therapy in IgAN. Our transition to a commercial-stage company marks a new chapter for Vera, as we deliver on our commitment to people living with IgAN,” said Marshall Fordyce, M.D., Founder and Chief Executive Officer of Vera Therapeutics. “We recently presented the final efficacy results from the ORIGIN 3 trial at ASN Kidney Week 2026, strengthening the clinical foundation for TRUTAKNA. The stabilization of kidney function at the physiologic rate and significant reduction in risk of composite kidney disease progression through two years reinforce the potential for TRUTAKNA to change the course of IgAN and supported our recent submission of an sBLA for full FDA approval.”
“Our team is executing on the launch priorities we established for TRUTAKNA, with growing interest from the IgAN community and approximately 700 PSFs received since launch,” added Matt Skelton, Chief Commercial Officer of Vera Therapeutics. “We are encouraged by the payer coverage policies taking shape. Our focus remains on expanding access and ensuring nephrologists have the tools and education they need to help eligible patients begin treatment with TRUTAKNA.”
Third Quarter 2026 and Recent Business Highlights
- Received FDA accelerated approval on July 7, 2026 for TRUTAKNA to reduce proteinuria in adults with primary IgAN at risk for disease progression. There are approximately 160,000 diagnosed IgAN patients in the U.S., roughly
75% of whom are commercially insured. - Launched TRUTAKNA in the U.S., drawing on a cross-functional team experienced in rare disease and kidney therapies. Received approximately 700 PSFs to date following TRUTAKNA’s accelerated approval.
- Presented detailed ORIGIN 3 final efficacy results as a late-breaking oral presentation at the opening plenary session of ASN Kidney Week 2026 with a simultaneous publication in The New England Journal of Medicine.1 TRUTAKNA met all prespecified endpoints, including eGFR change from baseline and annualized slope, and risk reduction in composite kidney disease progression events. Through 104 weeks, the annualized eGFR slope was -0.6 mL/min/1.73m²/year with TRUTAKNA compared with -5.6 mL/min/1.73m²/year with placebo, a treatment difference of 5.0 mL/min/1.73m²/year (p<0.0001). The ORIGIN 3 safety profile was favorable, and generally comparable to placebo.
- Presented interim results from the adult IgAN and primary membranous nephropathy (pMN) cohorts of the Phase 2 PIONEER basket trial of atacicept as a late-breaking research oral presentation and outlined the trial’s evaluation of pediatric patients with IgAN in an informational poster at ASN Kidney Week 2026. These interim results support the continued investigation of atacicept in antibody-mediated glomerular diseases.
- Completed supplemental Biologics License Application (sBLA) submission to the FDA on November 3, 2026 for full approval of TRUTAKNA in adults with primary IgAN, based on the ORIGIN 3 final efficacy analysis.
Anticipated Upcoming Milestones
- Potential full approval of TRUTAKNA in adults with primary IgAN, subject to FDA review of the sBLA, expected in mid-2027.
- Planned Marketing Authorisation Application submission to the European Medicines Agency expected in Q1 2027 for standard marketing authorisation.
Financial Results for the Quarter Ended September 30, 2026
For the quarter ended September 30, 2026, Vera Therapeutics reported net product revenue of
During the nine months ended September 30, 2026, net cash used in operating activities was
Vera Therapeutics reported
Investor Webcast
The Company’s management team will host a live investor webcast at 4:30 p.m. ET today, November 5, 2026, to discuss the third quarter 2026 financial results and business updates. The live webcast can be accessed directly here and through the Investors & Media section of the Company’s website at https://ir.veratx.com. A replay will be available on the Company’s website following the live event.
TRUTAKNA (atacicept-vymj) 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
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 (≥
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
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
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
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 potential for TRUTAKNA to stabilize kidney function; TRUTAKNA’s potential to become a foundational therapy in IgAN; the potential for TRUTAKNA to change the course of IgAN; how payer coverage policies will address TRUTAKNA; the potential for TRUTAKNA to receive full approval from the FDA and the timing of such approval; Vera Therapeutics’ plan to submit a Marketing Authorisation Application to the European Medicines Agency and the timing of such submission; the availability and conditions of additional borrowing capacity under Vera Therapeutics’ debt facility; 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. Barratt J, et al. N Engl J Med 2026. doi/full/10.1056/NEJMoa2610103.
2. TRUTAKNA™ Prescribing Information. Brisbane, CA: Vera Therapeutics, Inc.; Revised 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
| VERA THERAPEUTICS, INC. Condensed Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (Unaudited) | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||
| Revenue: | ||||||||||||
| Product revenue, net | $ | 10,277 | — | $ | 10,277 | — | ||||||
| Operating expenses: | ||||||||||||
| Cost of sales | 3,296 | — | 3,296 | — | ||||||||
| Research and development | 41,253 | 56,473 | 187,344 | 155,946 | ||||||||
| Selling, general and administrative | 61,430 | 27,459 | 152,961 | 65,321 | ||||||||
| Total operating expenses | 105,979 | 83,932 | 343,601 | 221,267 | ||||||||
| Loss from operations | (95,702 | ) | (83,932 | ) | (333,324 | ) | (221,267 | ) | ||||
| Other income, net | 1,991 | 3,639 | 9,108 | 12,749 | ||||||||
| Net loss | $ | (93,711 | ) | $ | (80,293 | ) | $ | (324,216 | ) | $ | (208,518 | ) |
| Change in unrealized gain (loss) on marketable securities | (301 | ) | 354 | (1,490 | ) | 488 | ||||||
| Comprehensive loss | (94,012 | ) | (79,939 | ) | (325,706 | ) | (208,030 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.30 | ) | $ | (1.26 | ) | $ | (4.51 | ) | $ | (3.27 | ) |
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 72,126,588 | 63,847,055 | 71,816,111 | 63,769,948 | ||||||||
| VERA THERAPEUTICS, INC. Condensed Balance Sheets (in thousands) (Unaudited) | ||||||
| September 30, 2026 | December 31, 2025 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash, cash equivalents and marketable securities | $ | 384,042 | $ | 714,589 | ||
| Accounts receivable, net | 11,981 | — | ||||
| Inventory | 7,078 | — | ||||
| Prepaid expenses and other assets, current | 38,184 | 14,294 | ||||
| Total current assets | 441,285 | 728,883 | ||||
| Intangible assets, net | 20,499 | — | ||||
| Other assets, noncurrent | 3,968 | 5,850 | ||||
| Total assets | $ | 465,752 | $ | 734,733 | ||
| Liabilities and stockholders’ equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | 20,173 | 21,898 | ||||
| Accrued expenses and other liabilities, current | 35,602 | 31,557 | ||||
| Total current liabilities | 55,775 | 53,455 | ||||
| Long-term debt | 75,434 | 74,838 | ||||
| Other liabilities, noncurrent | 1,357 | 1,919 | ||||
| Total liabilities | 132,566 | 130,212 | ||||
| Stockholders’ equity: | ||||||
| Common stock | 72 | 71 | ||||
| Additional paid-in capital | 1,418,899 | 1,364,529 | ||||
| Accumulated other comprehensive (loss) income | (704 | ) | 786 | |||
| Accumulated deficit | (1,085,081 | ) | (760,865 | ) | ||
| Total stockholders’ equity | 333,186 | 604,521 | ||||
| Total liabilities and stockholders’ equity | $ | 465,752 | $ | 734,733 | ||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much TRUTAKNA revenue did Vera Therapeutics report for Q3 2026?
Vera reported $10.3 million in net product revenue for the quarter ended September 30, 2026, compared with no product revenue in the prior-year quarter. TRUTAKNA received accelerated FDA approval on July 7, 2026, and approximately 700 Patient Start Forms have been received since launch.
What did Vera Therapeutics report from the ORIGIN 3 final efficacy analysis?
ORIGIN 3 met all prespecified endpoints and showed a 76% reduction in composite kidney disease progression risk versus placebo through two years. Through 104 weeks, the annualized estimated glomerular filtration rate slope—a measure of kidney filtration change—was -0.6 with TRUTAKNA versus -5.6 mL/min/1.73m²/year with placebo, a treatment difference of 5.0 mL/min/1.73m²/year (p<0.0001).
Why did Vera Therapeutics’ Q3 2026 research and development expense decline?
The decrease primarily reflected lower contract manufacturing expenses after commercial-supply manufacturing costs began being capitalized as inventory following TRUTAKNA’s July 7, 2026 accelerated approval. Those costs had previously been classified as research and development expense. Quarterly research and development expense was $41.3 million, compared with $56.5 million a year earlier.