Vera Therapeutics (VERA) gains FDA accelerated approval as Q2 loss widens
Rhea-AI Filing Summary
Vera Therapeutics, Inc. reported second quarter 2026 results and highlighted a major regulatory milestone. The company received FDA accelerated approval for TRUTAKNA in adult patients with primary IgA nephropathy (IgAN) at risk for disease progression and has begun a U.S. commercial launch. TRUTAKNA is the first approved therapy that inhibits both BAFF and APRIL, with Phase 3 ORIGIN data showing a 46% proteinuria reduction from baseline at 36 weeks and a 42% reduction versus placebo, plus a 68% reduction in galactose-deficient IgA1 and hematuria resolution in 81% of affected patients.
For the quarter ended June 30, 2026, Vera reported a net loss of $109.5 million, or $1.52 per share, compared with a $76.5 million loss, or $1.20 per share, a year earlier. Operating expenses rose to $112.5 million from $80.1 million, reflecting higher research and development and general and administrative spending. As of June 30, 2026, the company held $499.2 million in cash, cash equivalents and marketable securities and has access to up to $425 million under a debt facility, subject to conditions, to support its TRUTAKNA launch and ongoing clinical programs. Management expects the ORIGIN 3 final efficacy analysis in Q3 2026, an sBLA filing in Q4 2026, and is targeting potential full approval in 2027.
Positive
- FDA accelerated approval for TRUTAKNA in adult IgAN patients provides Vera with its first commercial product and a differentiated, first- and-only BAFF/APRIL inhibitor in this indication.
- Strong Phase 3 data for TRUTAKNA include a 46% proteinuria reduction from baseline and 42% reduction versus placebo, supporting its positioning as a potential foundational IgAN therapy.
- Vera ended June 30, 2026 with $499.2 million in cash, cash equivalents and marketable securities and access to up to $425 million in additional debt capacity, giving substantial funding for launch and trials.
Negative
- Quarterly net loss widened to $109.5 million (from $76.5 million a year earlier), with higher R&D and G&A expenses driving total operating expenses to $112.5 million.
- Cash, cash equivalents and marketable securities declined from $714.6 million at December 31, 2025 to $499.2 million at June 30, 2026, reflecting significant cash burn ahead of TRUTAKNA revenue ramp.
Filing Explained
Accelerated approval permits TRUTAKNA’s launch, but continued approval may depend on confirmatory evidence of long-term clinical benefit.
This Form 8-K reports that TRUTAKNA’s U.S. commercial launch is underway under FDA accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.
The approval is based on proteinuria reduction; the filing says it has not been established whether TRUTAKNA slows long-term kidney-function decline, and continued approval may depend on confirmatory evidence of clinical benefit.
As of
8-K Event Classification
Key Figures
Key Terms
accelerated approval regulatory
supplemental Biologics License Application regulatory
IgA nephropathy medical
BAFF and APRIL inhibitor medical
proteinuria medical
galactose-deficient IgA1 medical
Earnings Snapshot
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What were Vera Therapeutics (VERA) key financial results for Q2 2026?
How much cash does Vera Therapeutics (VERA) have to fund TRUTAKNA and its pipeline?
What regulatory milestone did Vera Therapeutics (VERA) achieve for TRUTAKNA?
What clinical data support TRUTAKNA’s use in IgA nephropathy for Vera Therapeutics (VERA)?
What upcoming milestones has Vera Therapeutics (VERA) outlined for TRUTAKNA?
How is Vera Therapeutics (VERA) supporting patient access to TRUTAKNA?
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition
On August 10, 2026, Vera Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2026, and providing recent corporate updates. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in this Current Report on Form 8-K (including Exhibit 99.1 hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Description |
99.1 |
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Press Release of Vera Therapeutics, Inc., dated August 10, 2026. |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Vera Therapeutics, Inc. |
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August 10, 2026 |
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/s/ Sean Grant |
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Sean Grant, Chief Financial Officer |
Exhibit 99.1
Vera Therapeutics Provides Business Update and Reports Second Quarter 2026 Financial Results
BRISBANE, Calif., August 10, 2026 – Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today reported its business highlights and financial results for the quarter ended June 30, 2026.
“The accelerated approval and commercial launch of TRUTAKNA represent transformative milestones for Vera Therapeutics and are the result of of years of hard work and dedication. We are extremely grateful to the patients, investigators, employees, and collaborators who have contributed to this moment,” said Marshall Fordyce, M.D., Founder and Chief Executive Officer of Vera Therapeutics. “We are thrilled that TRUTAKNA is available to eligible patients as the first and only therapy to inhibit both BAFF and APRIL in IgAN patients. We are focused on a successful U.S. launch of TRUTAKNA, and we continue to advance the ORIGIN 3 program in support of a potential full approval.”
“Our team has decades of experience commercializing innovative therapies, successfully launching multiple blockbusters and kidney therapies,” added Matt Skelton, Chief Commercial Officer of Vera Therapeutics. "Since receiving approval, our team has been promoting TRUTAKNA, and the early reception has been encouraging. We are laying the groundwork for long-term leadership in helping IgAN patients. We believe that the efficacy and safety profile of TRUTAKNA and the quality of our people will allow us to effectively serve nephrologists and IgAN patients in their treatment decisions.”
TRUTAKNA Launch Update
Second Quarter 2026 and Recent Business Highlights
Anticipated Upcoming Milestones
Financial Results for the Quarter Ended June 30, 2026
For the quarter ended June 30, 2026, Vera Therapeutics reported a net loss of $109.5 million, or a net loss per share of $1.52, compared to a net loss of $76.5 million, or a net loss per share of $1.20, for the quarter ended June 30, 2025.
During the six months ended June 30, 2026, net cash used in operating activities was $206.8 million, compared to $109.2 million for the quarter ended June 30, 2025.
Vera Therapeutics reported $499.2 million in cash, cash equivalents, and marketable securities as of June 30, 2026, plus up to $425 million available under its debt facility, subject to the satisfaction of certain conditions.
About IgAN
IgAN is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide.2,3Approximately 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
About TRUTAKNA (atacicept-vymj)
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 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.2 TRUTAKNA is self-administered as an at-home, small-volume (1ml), 150mg once-weekly autoinjector.
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.
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 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 the FDA to grant full approval to TRUTAKNA and the timing of such approval; the potential success of TRUTAKNA's U.S. commercial launch; the advancement of the ORIGIN 3 program; future reception to TRUTAKNA; Vera Therapeutics' ability for long-term leadership in IgAN; Vera Therapeutics' ability to effectively serve nephrologists and IgAN patients; TRUTAKNA's ability to address significant patient need and become a foundational therapy in IgAN; the number of patients impacted by IgAN in the U.S. and the percentage of those patients commercially insured; the potential out-of-pocket costs through the TRUTAKNA TRU SUPPORT™ program; the safety and efficacy profile of TRUTAKNA; the expected results and timing of the results of the ORIGIN 3 final efficacy analysis; the expected timing of sBLA submission to the FDA; the expected timing of additional PIONEER clinical results; 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
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 |
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Six Months Ended |
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||||||||||
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June 30, |
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June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
$ |
60,080 |
|
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$ |
58,195 |
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$ |
146,091 |
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$ |
99,473 |
|
General and administrative |
|
52,410 |
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21,946 |
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91,531 |
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37,862 |
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Total operating expenses |
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112,490 |
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80,141 |
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237,622 |
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137,335 |
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Loss from operations |
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(112,490 |
) |
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(80,141 |
) |
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(237,622 |
) |
|
|
(137,335 |
) |
Other income, net |
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3,017 |
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|
|
3,610 |
|
|
|
7,117 |
|
|
|
9,110 |
|
Net loss |
$ |
(109,473 |
) |
|
$ |
(76,531 |
) |
|
$ |
(230,505 |
) |
|
$ |
(128,225 |
) |
Change in unrealized gain/loss on marketable securities |
$ |
(247 |
) |
|
$ |
(127 |
) |
|
$ |
(1,189 |
) |
|
$ |
134 |
|
Comprehensive loss |
$ |
(109,720 |
) |
|
$ |
(76,658 |
) |
|
$ |
(231,694 |
) |
|
$ |
(128,091 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(1.52 |
) |
|
$ |
(1.20 |
) |
|
$ |
(3.22 |
) |
|
$ |
(2.01 |
) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
|
71,838,008 |
|
|
|
63,789,303 |
|
|
|
71,658,300 |
|
|
|
63,730,756 |
|
VERA THERAPEUTICS, INC.
Condensed Balance Sheets
(in thousands)
(Unaudited)
|
June 30, |
|
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December 31, |
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||
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2026 |
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2025 |
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Assets |
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Current assets: |
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Cash, cash equivalents and marketable securities |
$ |
499,161 |
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$ |
714,589 |
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Prepaid expenses and other assets, current |
|
28,332 |
|
|
|
14,294 |
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Total current assets |
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527,493 |
|
|
|
728,883 |
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Other assets, noncurrent |
|
5,491 |
|
|
|
5,850 |
|
Total assets |
$ |
532,984 |
|
|
$ |
734,733 |
|
|
|
|
|
|
|
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Liabilities and stockholders' equity |
|
|
|
|
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Current liabilities: |
|
|
|
|
|
||
Accounts payable |
$ |
14,573 |
|
|
$ |
21,898 |
|
Accrued expenses and other liabilities, current |
|
33,748 |
|
|
|
31,557 |
|
Total current liabilities |
|
48,321 |
|
|
|
53,455 |
|
Long-term debt |
|
75,228 |
|
|
|
74,838 |
|
Other liabilities, noncurrent |
|
1,677 |
|
|
|
1,919 |
|
Total liabilities |
|
125,226 |
|
|
|
130,212 |
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Stockholders' equity |
|
|
|
|
|
||
Common stock |
|
72 |
|
|
|
71 |
|
Additional paid-in-capital |
|
1,399,459 |
|
|
|
1,364,529 |
|
Accumulated other comprehensive (loss) income |
|
(403 |
) |
|
|
786 |
|
Accumulated deficit |
|
(991,370 |
) |
|
|
(760,865 |
) |
Total stockholders' equity |
|
407,758 |
|
|
|
604,521 |
|
Total liabilities and stockholders' equity |
$ |
532,984 |
|
|
$ |
734,733 |
|
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