RankAlpha logo
Back to Rankings

VERA

Vera TherapeuticsC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
Last Price
Quote time unavailable
View Chart
Documents
10
Stored
Transcripts
0
Recent loaded
Latest document
2026-10-23
Related article

Document history

Transcripts and related coverage stored for VERA. Related articles may discuss other companies and are not verified issuer releases.

10 shown
Related articleQuarter not tagged2026-10-23

Vera Therapeutics' TRUTAKNA Delivers Strong Phase III IgA Nephropathy Results

MarketBeat
- Interested in Vera Therapeutics, Inc.? Here are five stocks we like better. - TRUTAKNA delivered strong Phase III efficacy results in IgA nephropathy, including a placebo-adjusted eGFR benefit of 11.1 mL/min at week 104, a 76% reduction in the composite kidney-disease progression endpoint, and no dialysis, transplant, or deaths among treated patients. - Atacicept also reduced proteinuria by 51% at week 52 and 60% at week 104, while most adverse events were mild or moderate and no clinically relevant hypogammaglobulinemia or opportunistic infections were reported. - Vera has begun launching TRUTAKNA in the U.S. following accelerated approval and plans to submit a supplemental biologics license application this quarter, with potential full FDA approval and an updated label expected in mid-2027. - 3 Biotech Firms With Major Potential Catalysts in the Coming Months Vera Therapeutics (NASDAQ:VERA) reported final efficacy results from its Phase III ORIGIN trial evaluating atacicept, marketed as TRUTAKNA, in adults with IgA nephropathy. The company presented the data at the American Society of Nephrology's Kidney Week meeting in Denver, alongside publication in The New England Journal of Medicine. The randomized, placebo-controlled global study evaluated weekly self-administered subcutaneous atacicept 150 mg in adults with IgA nephropathy who had persistent proteinuria despite optimized supportive care. According to Jonathan Barratt, Mayer Professor of Medicine at the University of Leicester, the enrolled population had an average estimated glomerular filtration rate, or eGFR, of about 65 mL/min and proteinuria of 2.2 grams per day. Most participants were receiving renin-angiotensin system inhibitors, while 60% to 65% were also using SGLT2 inhibitors. → Aurora Rejects Curaleaf's Higher Bid, But the Takeover Fight Isn't Over - Analysts Can't Get Enough of These Little-Known Biopharma Stocks Barratt said atacicept produced a placebo-adjusted eGFR difference of 5.6 mL/min at week 52 and 11.1 mL/min at week 104. The annualized placebo-adjusted difference in eGFR slope was 5 mL/min per year. Patients receiving atacicept lost less than 1 mL/min of kidney function annually, according to Barratt, which he said is consistent with the treatment target outlined in KDIGO guidance. In contrast, he said patients in the placebo arm experienced substantially faster kidney-functi…Read full document

- Interested in Vera Therapeutics, Inc.? Here are five stocks we like better. - TRUTAKNA delivered strong Phase III efficacy results in IgA nephropathy, including a placebo-adjusted eGFR benefit of 11.1 mL/min at week 104, a 76% reduction in the composite kidney-disease progression endpoint, and no dialysis, transplant, or deaths among treated patients. - Atacicept also reduced proteinuria by 51% at week 52 and 60% at week 104, while most adverse events were mild or moderate and no clinically relevant hypogammaglobulinemia or opportunistic infections were reported. - Vera has begun launching TRUTAKNA in the U.S. following accelerated approval and plans to submit a supplemental biologics license application this quarter, with potential full FDA approval and an updated label expected in mid-2027. - 3 Biotech Firms With Major Potential Catalysts in the Coming Months Vera Therapeutics (NASDAQ:VERA) reported final efficacy results from its Phase III ORIGIN trial evaluating atacicept, marketed as TRUTAKNA, in adults with IgA nephropathy. The company presented the data at the American Society of Nephrology's Kidney Week meeting in Denver, alongside publication in The New England Journal of Medicine. The randomized, placebo-controlled global study evaluated weekly self-administered subcutaneous atacicept 150 mg in adults with IgA nephropathy who had persistent proteinuria despite optimized supportive care. According to Jonathan Barratt, Mayer Professor of Medicine at the University of Leicester, the enrolled population had an average estimated glomerular filtration rate, or eGFR, of about 65 mL/min and proteinuria of 2.2 grams per day. Most participants were receiving renin-angiotensin system inhibitors, while 60% to 65% were also using SGLT2 inhibitors. → Aurora Rejects Curaleaf's Higher Bid, But the Takeover Fight Isn't Over - Analysts Can't Get Enough of These Little-Known Biopharma Stocks Barratt said atacicept produced a placebo-adjusted eGFR difference of 5.6 mL/min at week 52 and 11.1 mL/min at week 104. The annualized placebo-adjusted difference in eGFR slope was 5 mL/min per year. Patients receiving atacicept lost less than 1 mL/min of kidney function annually, according to Barratt, which he said is consistent with the treatment target outlined in KDIGO guidance. In contrast, he said patients in the placebo arm experienced substantially faster kidney-function loss. → Could Quantinuum's Breakthrough Make Its Sell-Off a Bargain? The study also showed a 76% reduction through week 104 in the composite kidney disease progression endpoint, which included a sustained 30% or greater decline in eGFR, sustained eGFR below 15, chronic dialysis, kidney transplant, or death. Barratt said no atacicept-treated patient developed dialysis-dependent kidney failure, required a kidney transplant, or died during the study. Vera and the FDA agreed to shift the study's primary kidney-function assessment from week 104 to week 52 after results from an earlier Phase IIb study and concerns about continued placebo exposure, Barratt said. Participants are now transitioning to open-label atacicept for the remainder of the trial. → IonQ's Bold Expansion Could Leave Shareholders Paying the Price Atacicept treatment was associated with placebo-adjusted proteinuria reductions of 51% at week 52 and 60% at week 104. The company also reported reductions of 67% and 65%, respectively, in galactose-deficient IgA1, a pathogenic form of IgA. Hematuria resolved in 97% of atacicept-treated patients at week 104, according to the presentation. Most adverse events were mild or moderate and resolved without treatment interruption or discontinuation, Barratt said. Injection-site reactions were also described as mild or moderate. The serious adverse-event rate was lower in the atacicept group than in the placebo group, and the company reported no clinically relevant hypogammaglobulinemia, opportunistic infections, or deaths in the atacicept group. Although anti-drug antibodies were observed, Barratt said they did not have a clinically meaningful effect on pharmacokinetics, pharmacodynamics, safety, or efficacy in ORIGIN. Chief Executive Officer Marshall Fordyce said TRUTAKNA received accelerated approval on July 7 and is being launched commercially in the United States. Vera plans to provide a commercial update alongside its third-quarter earnings release in November. Fordyce said the company has started preparing a supplemental biologics license application to be submitted during the current quarter. Vera expects FDA review to potentially lead to full approval and an updated label in mid-2027. Barratt separately said a U.S. FDA submission supporting potential full approval is expected in 2027, with additional regional regulatory submissions planned afterward. Fordyce said the company expects the ability to actively promote the full efficacy dataset after a potential full-approval label update. Chief Commercial Officer Matt Skelton said he expects "a nice inflection point" once the company can promote the comprehensive dataset. During the question-and-answer session, Barratt said ORIGIN enrolled what he characterized as one of the highest-risk IgA nephropathy populations studied in a Phase III trial. He cautioned against direct comparisons with other studies because of differences in patient populations, follow-up duration, and composite endpoint definitions. Barratt also said treatment approaches are shifting toward simultaneous management of disease biology and chronic kidney disease factors rather than a prolonged observation period following use of supportive therapies. He argued that treatment decisions should not rely solely on residual proteinuria, citing the kidney-function findings observed with atacicept. Vera said it also presented data at Kidney Week involving adolescents with IgA nephropathy and planned to present initial data for atacicept in membranous nephropathy, another autoantibody-driven kidney disease. Vera Therapeutics, Inc is a clinical-stage biotechnology company focused on developing treatments for immunological diseases. The company's research is centered on therapies that target the underlying causes of autoimmune conditions rather than primarily addressing their symptoms. Vera's lead product candidate is atacicept, a biologic designed to inhibit the B-cell survival factors BLyS and APRIL. The company has been evaluating atacicept in IgA nephropathy, an autoimmune kidney disease that can lead to progressive loss of kidney function, and has also investigated its potential in other immune-mediated diseases. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Vera Therapeutics' TRUTAKNA Delivers Strong Phase III IgA Nephropathy Results" was originally published by MarketBeat. View MarketBeat's top stocks for October 2026.

Related articleQuarter not tagged2026-10-20

Vera Therapeutics to Host ASN Kidney Week Investor Webcast and Third Quarter 2026 Financial Results Conference Webcast

GlobeNewswire
- Investor webcast at 4:30 p.m. ET on October 22 to discuss ORIGIN 3 final efficacy results for TRUTAKNA™ (atacicept-vymj) featured in a late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2026 - Q3 2026 financial results investor webcast scheduled at 4:30 p.m. ET on November 5 BRISBANE, Calif., Oct. 20, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that it will host two upcoming investor webcasts to discuss ORIGIN 3 final efficacy results as presented at the American Society of Nephrology (ASN) Kidney Week 2026 and its third quarter 2026 financial results and business updates. ASN Kidney Week 2026 Investor Webcast The Company's management team will host a live investor webcast at 4:30 p.m. ET on Thursday, October 22, 2026, to discuss the final efficacy analysis from the ORIGIN 3 clinical trial of TRUTAKNA in IgA nephropathy (IgAN), which will be featured in a late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2026. Participants can register for the company's webcast here. A replay of the webcast will be available for 90 days and can be accessed by visiting the "News & Events" section of the Investors page of the Company's website. Joining the Company's management team will be Jonathan Barratt, PhD, FRCP, Mayer Professor of Renal Medicine at the University of Leicester. A live question and answer session will follow the presentation. About Jonathan Barratt, PhD, FRCP: Dr. Barratt leads the Renal Research Group within the College of Life Sciences, University of Leicester. His research is focused on a bench-to-bedside approach to improving the understanding of the pathogenesis of IgAN, a common global cause of kidney failure. Dr. Barratt is the IgAN Rare Disease Group lead for the UK National Registry of Rare Kidney Diseases, and a member of the steering committee for the International IgAN Network. He works closely with pharmaceutical companies interested in new treatments for IgAN, is Chief Investigator for a number of international randomized controlled Phase 2 and 3 clinical trials in IgAN, and was a member of the U.S. Food and Drug Administration and American Society of Nephrology Kidney Health Initiative: Identifying Surrogate Endpoints for Clinical Trials in IgAN Workgroup. Third Quarter 2026 Financial Results…Read full document

- Investor webcast at 4:30 p.m. ET on October 22 to discuss ORIGIN 3 final efficacy results for TRUTAKNA™ (atacicept-vymj) featured in a late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2026 - Q3 2026 financial results investor webcast scheduled at 4:30 p.m. ET on November 5 BRISBANE, Calif., Oct. 20, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that it will host two upcoming investor webcasts to discuss ORIGIN 3 final efficacy results as presented at the American Society of Nephrology (ASN) Kidney Week 2026 and its third quarter 2026 financial results and business updates. ASN Kidney Week 2026 Investor Webcast The Company's management team will host a live investor webcast at 4:30 p.m. ET on Thursday, October 22, 2026, to discuss the final efficacy analysis from the ORIGIN 3 clinical trial of TRUTAKNA in IgA nephropathy (IgAN), which will be featured in a late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2026. Participants can register for the company's webcast here. A replay of the webcast will be available for 90 days and can be accessed by visiting the "News & Events" section of the Investors page of the Company's website. Joining the Company's management team will be Jonathan Barratt, PhD, FRCP, Mayer Professor of Renal Medicine at the University of Leicester. A live question and answer session will follow the presentation. About Jonathan Barratt, PhD, FRCP: Dr. Barratt leads the Renal Research Group within the College of Life Sciences, University of Leicester. His research is focused on a bench-to-bedside approach to improving the understanding of the pathogenesis of IgAN, a common global cause of kidney failure. Dr. Barratt is the IgAN Rare Disease Group lead for the UK National Registry of Rare Kidney Diseases, and a member of the steering committee for the International IgAN Network. He works closely with pharmaceutical companies interested in new treatments for IgAN, is Chief Investigator for a number of international randomized controlled Phase 2 and 3 clinical trials in IgAN, and was a member of the U.S. Food and Drug Administration and American Society of Nephrology Kidney Health Initiative: Identifying Surrogate Endpoints for Clinical Trials in IgAN Workgroup. Third Quarter 2026 Financial Results Investor Webcast The Company's management team will host a live investor webcast at 4:30 p.m. ET on Thursday, November 5, 2026, to discuss the third quarter 2026 financial results and business updates. Participants can register for the webcast here. A replay of the webcast will be available for 90 days and can be accessed by visiting the "News & Events" section of the Investors page of the Company's website. 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 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 [email protected]. 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.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 (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.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 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 as 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. 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 For more information, please contact: Investor Contact: Joshua Qin Vera Therapeutics 650-360-6978 [email protected] Media Contact: Debra Charlesworth Vera Therapeutics 415-854-8051 [email protected]

Related articleQuarter not tagged2026-09-15

Why Vera Therapeutics Stock Is Jumping on New Kidney Drug Trial Results

Barrons.com

Vera Therapeutics takes a step toward securing full Food and Drug Administration approval for its injectable kidney drug, Trutakna.

Related articleQuarter not tagged2026-08-10

Vera Therapeutics Provides Business Update and Reports Second Quarter 2026 Financial Results

GlobeNewswire
TRUTAKNA™ granted accelerated approval by U.S. Food and Drug Administration (FDA) in adult patients with primary IgA nephropathy (IgAN) at risk for disease progression. Alignment with FDA on earlier ORIGIN 3 final efficacy analysis to support potential full approval for TRUTAKNA in adults with IgAN; results expected in Q3 2026. Anticipated supplemental Biologics License Application (sBLA) submission to the FDA – expected in Q4 2026. BRISBANE, Calif., Aug. 10, 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 June 30, 2026. “The accelerated approval and commercial launch of TRUTAKNA represent transformative milestones for Vera Therapeutics and are the result 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 TRUTAKNA positioned to address significant patient need as the first and only BAFF and APRIL inhibitor approved for IgAN. IgAN is a serious, progressive kidney disease driven by B-cell–mediated immune complex formation. TRUTAKNA is the first FDA-approved therapy to target both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), the key upstream drivers of IgAN pathophysiology.1 There are approximately 160,000 diagn…Read full document

TRUTAKNA™ granted accelerated approval by U.S. Food and Drug Administration (FDA) in adult patients with primary IgA nephropathy (IgAN) at risk for disease progression. Alignment with FDA on earlier ORIGIN 3 final efficacy analysis to support potential full approval for TRUTAKNA in adults with IgAN; results expected in Q3 2026. Anticipated supplemental Biologics License Application (sBLA) submission to the FDA – expected in Q4 2026. BRISBANE, Calif., Aug. 10, 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 June 30, 2026. “The accelerated approval and commercial launch of TRUTAKNA represent transformative milestones for Vera Therapeutics and are the result 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 TRUTAKNA positioned to address significant patient need as the first and only BAFF and APRIL inhibitor approved for IgAN. IgAN is a serious, progressive kidney disease driven by B-cell–mediated immune complex formation. TRUTAKNA is the first FDA-approved therapy to target both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), the key upstream drivers of IgAN pathophysiology.1 There are approximately 160,000 diagnosed IgAN patients in the U.S., roughly ~75% of whom are commercially insured. Strong clinical profile positions TRUTAKNA as a potential foundational therapy in IgAN. The accelerated approval of TRUTAKNA was based on results from the ORIGIN Phase 3 trial, published in the New England Journal of Medicine in November 2025.2 At 36 weeks, TRUTAKNA demonstrated a 46% reduction from baseline and 42% reduction versus placebo in proteinuria, with consistent benefit across all prespecified subgroups. TRUTAKNA-treated patients also showed a 68% reduction in galactose-deficient IgA1 (Gd-IgA1) and resolution of hematuria in 81% of patients with hematuria at baseline. TRUTAKNA was generally well tolerated, with no serious, severe, or opportunistic infections and no cases of hypogammaglobulinemia observed. In addition, there were no clinically significant effects of anti-drug antibodies on the pharmacokinetics, pharmacodynamics, safety, or efficacy of TRUTAKNA over the treatment period. TRUTAKNA is a once-weekly, at-home autoinjector, a desirable presentation for patients with proven success in other diseases. Experienced team executing on U.S. specialty launch. Vera Therapeutics has assembled an experienced cross-functional organization across sales, marketing, market access, patient support, and medical affairs with decades of experience in rare disease and kidney therapies. Eligible commercially insured patients may pay as little as $0 out of pocket through the TRUTAKNA TRU SUPPORT™ program. Second Quarter 2026 and Recent Business Highlights Received FDA accelerated approval for TRUTAKNA to reduce proteinuria in adult patients with primary IgAN at risk for disease progression U.S. commercial launch of TRUTAKNA, the first and only available therapy that binds both BAFF and APRIL, is underway Aligned with the FDA on an earlier ORIGIN 3 final efficacy analysis to support potential full approval of TRUTAKNA in adults with IgAN Announced the appointment of Nancy Boman, M.D., Ph.D. as Chief Regulatory Officer of Vera Therapeutics, succeeding William Turner, effective upon his retirement and transition to the role of Strategic Advisor in the third quarter of 2026 TRUTAKNA extended dose range finding study enrollment complete Anticipated Upcoming Milestones Final efficacy analysis from the ORIGIN 3 trial expected in Q3 2026 Anticipated sBLA submission to the FDA expected in Q4 2026 Additional PIONEER clinical results expected in Q4 2026 Potential full approval of TRUTAKNA in IgAN expected in 2027 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 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.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 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.3 TRUTAKNA is self-administered as an at-home, small-volume (1 ml), 150 mg 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 [email protected]. 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. 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 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 QinVera [email protected] Media Contact:Debra CharlesworthVera [email protected]

Related articleQuarter not tagged2026-05-07

Vera Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results

GlobeNewswire
U.S. Food and Drug Administration (FDA) granted priority review to Biologics License Application (BLA) for the accelerated approval of atacicept in adult patients with IgA Nephropathy (IgAN) with a Prescription Drug User Fee Act (PDUFA) date of July 7, 2026 On track for U.S. commercial launch of atacicept in mid-2026, pending regulatory approval Strong balance sheet expected to be sufficient to fund operations beyond potential atacicept approval and U.S. commercial launch BRISBANE, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the first quarter ended March 31, 2026. “The team at Vera Therapeutics is focused on execution as we advance atacicept toward potential FDA accelerated approval in IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “During the first quarter, we made meaningful progress across key pre‑commercial activities, including in sales, marketing, market access, compliance, and commercial operations, to support a successful U.S. launch, pending regulatory approval. We are excited for atacicept to potentially be the first approved drug targeting both BAFF and APRIL in IgAN patients.” First Quarter 2026 and Recent Business Highlights FDA granted Priority Review to the atacicept BLA for the treatment of IgAN in adults, and assigned a PDUFA target action date of July 7, 2026 Vera Therapeutics continues to advance preparations ahead of potential commercial launch in mid-2026 Company bolsters its executive team and Board of Directors with the promotion of Matt Skelton to Chief Commercial Officer and the appointments of accomplished biopharma leaders, Jane Wright-Mitchell as Chief Legal Officer, and Christopher Hite as a member of the Board of Directors Strong balance sheet expected to be sufficient to fund operations beyond the potential approval and U.S. commercial launch of atacicept Anticipated Upcoming Milestones Potential FDA accelerated approval of atacicept in IgAN with a PDUFA date of July 7, 2026 Planned U.S. commercial launch of atacicept expected mid-2026, pending FDA approval Initial results from PIONEER, a Phase 2 basket trial evaluating atacicept in expanded IgAN populations and…Read full document

U.S. Food and Drug Administration (FDA) granted priority review to Biologics License Application (BLA) for the accelerated approval of atacicept in adult patients with IgA Nephropathy (IgAN) with a Prescription Drug User Fee Act (PDUFA) date of July 7, 2026 On track for U.S. commercial launch of atacicept in mid-2026, pending regulatory approval Strong balance sheet expected to be sufficient to fund operations beyond potential atacicept approval and U.S. commercial launch BRISBANE, Calif., May 07, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the first quarter ended March 31, 2026. “The team at Vera Therapeutics is focused on execution as we advance atacicept toward potential FDA accelerated approval in IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “During the first quarter, we made meaningful progress across key pre‑commercial activities, including in sales, marketing, market access, compliance, and commercial operations, to support a successful U.S. launch, pending regulatory approval. We are excited for atacicept to potentially be the first approved drug targeting both BAFF and APRIL in IgAN patients.” First Quarter 2026 and Recent Business Highlights FDA granted Priority Review to the atacicept BLA for the treatment of IgAN in adults, and assigned a PDUFA target action date of July 7, 2026 Vera Therapeutics continues to advance preparations ahead of potential commercial launch in mid-2026 Company bolsters its executive team and Board of Directors with the promotion of Matt Skelton to Chief Commercial Officer and the appointments of accomplished biopharma leaders, Jane Wright-Mitchell as Chief Legal Officer, and Christopher Hite as a member of the Board of Directors Strong balance sheet expected to be sufficient to fund operations beyond the potential approval and U.S. commercial launch of atacicept Anticipated Upcoming Milestones Potential FDA accelerated approval of atacicept in IgAN with a PDUFA date of July 7, 2026 Planned U.S. commercial launch of atacicept expected mid-2026, pending FDA approval Initial results from PIONEER, a Phase 2 basket trial evaluating atacicept in expanded IgAN populations and other autoimmune kidney diseases, expected in Q2 2026 Pivotal two-year eGFR data from the ORIGIN 3 trial expected Q1 2027 Financial Results for the Quarter Ended March 31, 2026 For the quarter ended March 31, 2026, Vera Therapeutics reported a net loss of $121.0 million, or a net loss per diluted share of $1.69, compared to a net loss of $51.7 million, or a net loss per diluted share of $0.81, for the quarter ended March 31, 2025. During the quarter ended March 31, 2026, net cash used in operating activities was $106.5 million, compared to $54.4 million for the quarter ended March 31, 2025. Vera Therapeutics reported $596.8 million in cash, cash equivalents, and marketable securities as of March 31, 2026, which combined with availability under its debt facility, Vera Therapeutics believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept and beyond. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with IgAN, lupus nephritis, and other autoimmune kidney diseases. About the Atacicept Clinical Program The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. The ORIGIN Phase 3 trial met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36, in the prespecified interim analysis. Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable, and comparable to placebo. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR, with results expected in Q1 2027. For more information about ORIGIN 3, please visit http://www.clinicaltrials.gov. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera Therapeutics believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different disease areas. The ORIGIN Extend study provides ORIGIN study participants with extended access to atacicept until its potential commercial availability in their region and captures longer-term safety and efficacy data. Atacicept is also being evaluated in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients in the PIONEER trial. The atacicept monthly dose range finding study was initiated in 2025 to explore the effectiveness, safety, and tolerability of different dosing regimens of atacicept. Enrollment in the study has been completed. About Vera Therapeutics Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also evaluating development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109 and MAU868. For more information, please 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, approval of atacicept by the FDA, including expected timing; the timing, preparedness and success of the commercial launch of atacicept in the U.S.; Vera Therapeutics' ability to fund operations beyond anticipated approval and U.S. commercial launch of atacicept; the potential for atacicept to be the first approved drug targeting both BAFF and APRIL in IgAN patients; timing of initial results from PIONEER; timing of completion of ORIGIN 3; atacicept’s positioning for best-in-class potential; 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. For more information, please contact: Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 [email protected] Media Contact: Debra Charlesworth Vera Therapeutics 415-854-8051 [email protected]

Related articleQuarter not tagged2026-03-17

This Biotech Stock Surged 75% Last Quarter and Pulled a New $9 Million Investment

Motley Fool
On February 17, 2026, Eversept Partners disclosed a buy of Vera Therapeutics (NASDAQ:VERA), adding 264,468 shares in a move estimated at $9.39 million based on quarterly average pricing. According to a SEC filing dated February 17, 2026, Eversept Partners increased its position in Vera Therapeutics by 264,468 shares in the fourth quarter. The estimated transaction value is approximately $9.39 million, calculated using the average share price for the quarter. At quarter-end, the value of the fund's Vera Therapeutics holding rose by $73.99 million, a figure that reflects both new purchases and stock price appreciation. Top holdings after the filing: NASDAQ: VERA: $155.58 million (8.7% of AUM) NYSE: GSK: $131.41 million (7.4% of AUM) NASDAQ: UTHR: $123.08 million (6.9% of AUM) NASDAQ: ABVX: $88.71 million (5.0% of AUM) NASDAQ: NTRA: $76.63 million (4.3% of AUM) As of Monday, Vera Therapeutics shares were priced at $39.97, up 43% over the past year and well outperforming the S&P 500’s roughly 19% gain in the same period. Vera Therapeutics develops clinical-stage therapies targeting serious immunological diseases, with a lead product candidate, atacicept, in Phase IIb trials for immunoglobulin A nephropathy, and MAU868 in Phase II for BK viremia infections. The company operates a biotechnology model focused on research, development, and commercialization of proprietary biologic drug candidates, aiming for regulatory approval and future revenue generation from product sales and potential licensing. Primary customers are healthcare providers and patients affected by autoimmune and viral-mediated kidney diseases, with a focus on the United States market. Vera Therapeutics is a clinical-stage biotechnology company specializing in immunological disease treatments, headquartered in Brisbane, California. The company leverages a robust pipeline of biologic candidates to address unmet medical needs in nephrology and infectious diseases. Its strategy centers on advancing innovative therapies through late-stage clinical development to establish a competitive position in the biopharmaceutical sector. Vera’s lead drug candidate, atacicept, is being developed to treat immunoglobulin A nephropathy, a serious kidney disease with limited treatment options. The therapy has already produced positive Phase 3 results and is now under priority review by the FDA, with a decision expect…Read full document

On February 17, 2026, Eversept Partners disclosed a buy of Vera Therapeutics (NASDAQ:VERA), adding 264,468 shares in a move estimated at $9.39 million based on quarterly average pricing. According to a SEC filing dated February 17, 2026, Eversept Partners increased its position in Vera Therapeutics by 264,468 shares in the fourth quarter. The estimated transaction value is approximately $9.39 million, calculated using the average share price for the quarter. At quarter-end, the value of the fund's Vera Therapeutics holding rose by $73.99 million, a figure that reflects both new purchases and stock price appreciation. Top holdings after the filing: NASDAQ: VERA: $155.58 million (8.7% of AUM) NYSE: GSK: $131.41 million (7.4% of AUM) NASDAQ: UTHR: $123.08 million (6.9% of AUM) NASDAQ: ABVX: $88.71 million (5.0% of AUM) NASDAQ: NTRA: $76.63 million (4.3% of AUM) As of Monday, Vera Therapeutics shares were priced at $39.97, up 43% over the past year and well outperforming the S&P 500’s roughly 19% gain in the same period. Vera Therapeutics develops clinical-stage therapies targeting serious immunological diseases, with a lead product candidate, atacicept, in Phase IIb trials for immunoglobulin A nephropathy, and MAU868 in Phase II for BK viremia infections. The company operates a biotechnology model focused on research, development, and commercialization of proprietary biologic drug candidates, aiming for regulatory approval and future revenue generation from product sales and potential licensing. Primary customers are healthcare providers and patients affected by autoimmune and viral-mediated kidney diseases, with a focus on the United States market. Vera Therapeutics is a clinical-stage biotechnology company specializing in immunological disease treatments, headquartered in Brisbane, California. The company leverages a robust pipeline of biologic candidates to address unmet medical needs in nephrology and infectious diseases. Its strategy centers on advancing innovative therapies through late-stage clinical development to establish a competitive position in the biopharmaceutical sector. Vera’s lead drug candidate, atacicept, is being developed to treat immunoglobulin A nephropathy, a serious kidney disease with limited treatment options. The therapy has already produced positive Phase 3 results and is now under priority review by the FDA, with a decision expected in July 2026. If approved, the drug could launch in the United States shortly afterward. Financially, the company has positioned itself for that moment. Vera ended 2025 with about $714 million in cash, cash equivalents, and marketable securities, a balance management believes can fund operations through a potential approval and launch. Investors have clearly taken notice. Shares rocketed more than 75% last quarter amid a major capital raise of roughly $261 million in stock priced at $42.50 per share. Within the broader portfolio, the position fits neatly alongside holdings in biotech and pharmaceutical innovators such as Ultragenyx, Abivax, and GSK, reinforcing a clear focus on high-impact medical breakthroughs. For Vera, the upcoming FDA decision could mark the turning point that determines whether the firm evolves from a promising biotech to a commercial drugmaker. Before you buy stock in Vera Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Vera Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $514,000!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,105,029!* Now, it’s worth noting Stock Advisor’s total average return is 930% — a market-crushing outperformance compared to 187% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of March 16, 2026. Jonathan Ponciano has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends United Therapeutics. The Motley Fool recommends GSK. The Motley Fool has a disclosure policy. This Biotech Stock Surged 75% Last Quarter and Pulled a New $9 Million Investment was originally published by The Motley Fool

Related articleQuarter not tagged2026-02-26

Vera Therapeutics Provides Business Update and Reports Full Year 2025 Financial Results

GlobeNewswire
Positive Phase 3 data from ORIGIN 3 study of atacicept in IgA nephropathy (IgAN) presented at American Society of Nephrology (ASN) Kidney Week and published in the New England Journal of Medicine U.S. Food and Drug Administration (FDA) granted priority review to Biologics License Application (BLA) for atacicept with Prescription Drug User Fee Act (PDUFA) date of July 7, 2026; potential commercial launch of atacicept expected in mid-2026 Strong balance sheet bolstered by equity and debt financings in 2025 expected to be sufficient to fund company beyond atacicept approval and U.S. commercial launch BRISBANE, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the full year ended December 31, 2025. “In 2025, Vera Therapeutics delivered on several key milestones as we advanced atacicept toward potential FDA approval and commercialization,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “The BLA has been granted priority review and we expect to be commercially prepared to successfully launch atacicept in IgAN in mid-2026 if approved. Our commercial team brings decades of experience launching innovative therapies and is eager to bring this potentially disease-modifying therapy to patients with IgAN and other autoimmune kidney diseases.” “Vera Therapeutics has established a leadership position within the IgAN space based on the compelling profile of atacicept. Data from the ORIGIN clinical program have shown that blocking BAFF and APRIL with atacicept results in clinically meaningful reductions to proteinuria, Gd-IgA1, and hematuria (Phase 2 and 3) and a stabilization of eGFR (Phase 2),” said Robert M. Brenner, M.D., Chief Medical Officer of Vera Therapeutics. “Vera is confident in the strength of the atacicept data package to support approval and deliver a potential new therapy to the IgAN patients and caregivers whom we serve.” Key Full Year 2025 and Recent Business Highlights Positive primary endpoint results from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgAN were presented in a featured late-breaking oral presentation during the opening plenary session of ASN Ki…Read full document

Positive Phase 3 data from ORIGIN 3 study of atacicept in IgA nephropathy (IgAN) presented at American Society of Nephrology (ASN) Kidney Week and published in the New England Journal of Medicine U.S. Food and Drug Administration (FDA) granted priority review to Biologics License Application (BLA) for atacicept with Prescription Drug User Fee Act (PDUFA) date of July 7, 2026; potential commercial launch of atacicept expected in mid-2026 Strong balance sheet bolstered by equity and debt financings in 2025 expected to be sufficient to fund company beyond atacicept approval and U.S. commercial launch BRISBANE, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the full year ended December 31, 2025. “In 2025, Vera Therapeutics delivered on several key milestones as we advanced atacicept toward potential FDA approval and commercialization,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “The BLA has been granted priority review and we expect to be commercially prepared to successfully launch atacicept in IgAN in mid-2026 if approved. Our commercial team brings decades of experience launching innovative therapies and is eager to bring this potentially disease-modifying therapy to patients with IgAN and other autoimmune kidney diseases.” “Vera Therapeutics has established a leadership position within the IgAN space based on the compelling profile of atacicept. Data from the ORIGIN clinical program have shown that blocking BAFF and APRIL with atacicept results in clinically meaningful reductions to proteinuria, Gd-IgA1, and hematuria (Phase 2 and 3) and a stabilization of eGFR (Phase 2),” said Robert M. Brenner, M.D., Chief Medical Officer of Vera Therapeutics. “Vera is confident in the strength of the atacicept data package to support approval and deliver a potential new therapy to the IgAN patients and caregivers whom we serve.” Key Full Year 2025 and Recent Business Highlights Positive primary endpoint results from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgAN were presented in a featured late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2025 and published in the New England Journal of Medicine FDA granted priority review to the atacicept BLA for the treatment of IgAN in adults, and assigned a PDUFA target action date of July 7, 2026; Vera Therapeutics plans for a potential commercial launch in mid-2026 Matt Skelton, Chief Commercial Officer, advancing preparations for U.S. commercial launch Appointed James R. Meyers, an accomplished biopharmaceutical executive with over three decades of commercial leadership experience, to Board of Directors Successfully completed an equity financing and entered into a debt agreement resulting in combined potential gross proceeds of $800 million, strengthening Vera Therapeutics’ balance sheet to fund operations beyond the potential approval and U.S. commercial launch of atacicept Anticipated Upcoming Milestones Potential FDA approval of atacicept in IgAN – PDUFA date of July 7, 2026 Planned U.S. commercial launch of atacicept, pending FDA approval – mid-2026 Initial results from PIONEER – a Phase 2 basket trial evaluating atacicept in expanded IgAN populations, and other autoimmune kidney diseases – expected in 1H 2026 Pivotal ORIGIN 3 study completion with two-year eGFR data – expected in 2027 Financial Results for the Year Ended December 31, 2025 For the year ended December 31, 2025, Vera Therapeutics reported a net loss of $299.6 million, or a net loss per diluted share of $4.66, compared to a net loss of $152.1 million, or a net loss per diluted share of $2.75, for the year ended December 31, 2024. During the year ended December 31, 2025, net cash used in operating activities was $241.1 million, compared to $134.7 million for the year ended December 31, 2024. Vera Therapeutics reported $714.6 million in cash, cash equivalents, and marketable securities as of December 31, 2025, which combined with availability under its debt facility, Vera Therapeutics believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept and beyond. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with IgAN, lupus nephritis, and other autoimmune kidney diseases. About the Atacicept Clinical Program The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. The ORIGIN Phase 3 trial met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36, in the prespecified interim analysis. Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable, and comparable to placebo. The trial continues in a placebo-controlled blinded manner to evaluate the change in kidney function over two years as measured by eGFR, with results expected in 2027. For more information about ORIGIN 3, please visit http://www.clinicaltrials.gov. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera Therapeutics believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different disease areas. The ORIGIN Extend study provides ORIGIN study participants with extended access to atacicept until its potential commercial availability in their region and captures longer-term safety and efficacy data. Atacicept is also being evaluated in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients in the PIONEER trial. About Vera Therapeutics Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell-mediated diseases. Vera Therapeutics is also evaluating development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109 and MAU868. For more information, please 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, approval of atacicept by the FDA, including expected timing; the timing, preparedness and success of the commercial launch of atacicept in the U.S.; the ability of atacicept to be a disease-modifying therapy for patients with IgAN and other autoimmune kidney diseases; Vera Therapeutics' confidence in the strength of the atacicept data package to support FDA approval; Vera Therapeutics' ability to fund operations beyond anticipated approval and U.S. commercial launch of atacicept; timing of initial results from PIONEER and completion of ORIGIN 3; atacicept’s positioning for best-in-class potential; 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. For more information, please contact: Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 [email protected] Media Contact: Debra Charlesworth Vera Therapeutics 415-854-8051 [email protected]

Related articleQuarter not tagged2025-11-05

Vera Therapeutics Provides Business Update and Reports Third Quarter 2025 Financial Results

GlobeNewswire
ORIGIN 3 trial primary endpoint results for Atacicept in IgA nephropathy (IgAN) selected as a featured late-breaking oral presentation during opening plenary session of American Society of Nephrology (ASN) Kidney Week 2025 Biologics License Application (BLA) submission through the Accelerated Approval Program for atacicept for the treatment of IgAN to U.S. FDA expected in Q4; potential U.S. commercial launch of atacicept in 2026 Actively enrolling patients in the PIONEER, atacicept monthly dose range finding, and ORIGIN Extend studies BRISBANE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the third quarter ended September 30, 2025. “We look forward to presenting the most recent data from the ORIGIN 3 trial in a late-breaking presentation during the opening plenary session of ASN Kidney Week later this week,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We are excited to share additional data and clinical experience regarding the treatment of IgAN, which remains an area of unmet need within the nephrology community.” “We remain on track to submit the BLA for atacicept in IgAN to the FDA this quarter. The BLA submission is supported by a robust data package that is built on years of rigorous clinical development, including the pivotal ORIGIN 3 trial, and we are looking forward to this major milestone in our mission to bring forward a potentially disease-modifying therapy for patients,” continued Dr. Fordyce. Third Quarter 2025 and Recent Business Highlights Primary endpoint results from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgAN selected as a featured late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2025 on November 6 Two additional posters scheduled to be presented during ASN Kidney Week 2025 Continue to enroll participants in the PIONEER Phase 2 basket trial to evaluate atacicept in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy (pMN), and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients Continue to enroll participants in th…Read full document

ORIGIN 3 trial primary endpoint results for Atacicept in IgA nephropathy (IgAN) selected as a featured late-breaking oral presentation during opening plenary session of American Society of Nephrology (ASN) Kidney Week 2025 Biologics License Application (BLA) submission through the Accelerated Approval Program for atacicept for the treatment of IgAN to U.S. FDA expected in Q4; potential U.S. commercial launch of atacicept in 2026 Actively enrolling patients in the PIONEER, atacicept monthly dose range finding, and ORIGIN Extend studies BRISBANE, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the third quarter ended September 30, 2025. “We look forward to presenting the most recent data from the ORIGIN 3 trial in a late-breaking presentation during the opening plenary session of ASN Kidney Week later this week,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We are excited to share additional data and clinical experience regarding the treatment of IgAN, which remains an area of unmet need within the nephrology community.” “We remain on track to submit the BLA for atacicept in IgAN to the FDA this quarter. The BLA submission is supported by a robust data package that is built on years of rigorous clinical development, including the pivotal ORIGIN 3 trial, and we are looking forward to this major milestone in our mission to bring forward a potentially disease-modifying therapy for patients,” continued Dr. Fordyce. Third Quarter 2025 and Recent Business Highlights Primary endpoint results from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgAN selected as a featured late-breaking oral presentation during the opening plenary session of ASN Kidney Week 2025 on November 6 Two additional posters scheduled to be presented during ASN Kidney Week 2025 Continue to enroll participants in the PIONEER Phase 2 basket trial to evaluate atacicept in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy (pMN), and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients Continue to enroll participants in the atacicept monthly dose range finding study Continue to enroll participants in the ORIGIN Extend study, which provides ORIGIN participants with extended access to atacicept until commercial availability in their region, and captures longer-term safety and efficacy data Anticipated Upcoming Milestones Presentation of 36-week results from the pivotal ORIGIN 3 trial at ASN Kidney Week 2025 on November 6, 2025 Investor call and webcast to provide an ORIGIN 3 update on November 6, 2025 BLA submission through the Accelerated Approval Program for atacicept for the treatment of IgAN in adults to the U.S. FDA expected in Q4 Initial results from the PIONEER trial expected in Q4 2025 Potential FDA approval and U.S. launch of atacicept in 2026 2-year data from the pivotal ORIGIN 3 trial expected in 2027 Financial Results for the Quarter Ended September 30, 2025 For the quarter ended September 30, 2025, Vera Therapeutics reported a net loss of $80.3 million, or a net loss per diluted share of $1.26, compared to a net loss of $46.6 million, or a net loss per diluted share of $0.85, for the quarter ended September 30, 2024. During the nine months ended September 30, 2025, net cash used in operating activities was $171.1 million, compared to $95.5 million for the same period last year. Vera Therapeutics reported $497.4 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which combined with availability under its debt facility, Vera believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept and beyond. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with IgAN, lupus nephritis, and other autoimmune kidney diseases. About the Atacicept Clinical Program The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. The ORIGIN Phase 3 trial met the primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at week 36, in the prespecified interim analysis. Across the ORIGIN program in IgAN, the safety profile of atacicept appears favorable, and comparable to placebo. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera Therapeutics believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different disease areas. The ORIGIN Extend study provides ORIGIN study participants with extended access to atacicept until its potential commercial availability in their region and captures longer-term safety and efficacy data. Atacicept is also being evaluated in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients in the PIONEER trial. About Vera Therapeutics Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell–mediated diseases. Vera Therapeutics is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. For more information, please 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 advancement, clinical development, regulatory milestones and commercialization of atacicept; the expected timing for filing the BLA, FDA approval, and the U.S. commercial launch of atacicept; Vera Therapeutics' ability to bring forward a potentially disease-modifying therapy for patients; expected timing for results from the PIONEER trial and 2-year data from the ORIGIN 3 trial; whether Vera Therapeutics is sufficiently funded through the potential approval and U.S. commercial launch for atacicept and beyond; the potential for atacicept to be best-in-class; and Vera Therapeutics’ plans, commitments, aspirations and goals under the caption “About Vera Therapeutics”. Words such as “believe,” “plan,” “potential” 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. For more information, please contact: Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 [email protected] Media Contact: Debra Charlesworth Vera Therapeutics 415-854-8051 [email protected]

Related articleQuarter not tagged2025-08-05

Vera Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results

GlobeNewswire
On track to submit a Biologics License Application (BLA) for accelerated approval of atacicept to U.S. FDA in Q4 2025; potential commercial launch in 2026 Announced positive primary endpoint results from the ongoing ORIGIN Phase 3 trial Initiated the PIONEER trial to investigate atacicept in a broader IgAN patient cohort and multiple autoimmune glomerular diseases Expected to present full primary endpoint results from the ORIGIN 3 trial at a medical congress in Q4 2025 BRISBANE, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the second quarter ended June 30, 2025. “Our team delivered exciting new clinical results from our pivotal ORIGIN 3 trial in the second quarter of 2025, which were consistent with or better than our previous trials for atacicept in patients with IgAN. Based on the strength of the overall data accumulated for atacicept over the past few years, we are excited to move ahead with our BLA submission to the U.S. FDA for accelerated approval. We anticipate submitting the BLA in the fourth quarter of 2025, with an expected commercial launch in 2026,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We are thrilled for the potential of atacicept as a possible disease-modifying therapy to address the unmet medical needs of IgAN patients.” Second Quarter 2025 and Recent Business Highlights Announced positive 36-week data from the ongoing pivotal ORIGIN 3 trial of atacicept in patients with IgA Nephropathy (IgAN), including: 46% reduction from baseline in proteinuria for participants treated with atacicept, as measured by 24-hour urine protein-to-creatinine ratio (UPCR); primary endpoint achieved with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) Atacicept-treated participants demonstrated results across other prespecified endpoints that were consistent with or better than those previously observed in the ORIGIN Phase 2b trial Safety profile of atacicept across ORIGIN program appears favorable, and comparabl…Read full document

On track to submit a Biologics License Application (BLA) for accelerated approval of atacicept to U.S. FDA in Q4 2025; potential commercial launch in 2026 Announced positive primary endpoint results from the ongoing ORIGIN Phase 3 trial Initiated the PIONEER trial to investigate atacicept in a broader IgAN patient cohort and multiple autoimmune glomerular diseases Expected to present full primary endpoint results from the ORIGIN 3 trial at a medical congress in Q4 2025 BRISBANE, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the second quarter ended June 30, 2025. “Our team delivered exciting new clinical results from our pivotal ORIGIN 3 trial in the second quarter of 2025, which were consistent with or better than our previous trials for atacicept in patients with IgAN. Based on the strength of the overall data accumulated for atacicept over the past few years, we are excited to move ahead with our BLA submission to the U.S. FDA for accelerated approval. We anticipate submitting the BLA in the fourth quarter of 2025, with an expected commercial launch in 2026,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Atacicept has the potential to advance the standard of care in IgAN as the first dual BAFF/APRIL inhibitor. We are thrilled for the potential of atacicept as a possible disease-modifying therapy to address the unmet medical needs of IgAN patients.” Second Quarter 2025 and Recent Business Highlights Announced positive 36-week data from the ongoing pivotal ORIGIN 3 trial of atacicept in patients with IgA Nephropathy (IgAN), including: 46% reduction from baseline in proteinuria for participants treated with atacicept, as measured by 24-hour urine protein-to-creatinine ratio (UPCR); primary endpoint achieved with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) Atacicept-treated participants demonstrated results across other prespecified endpoints that were consistent with or better than those previously observed in the ORIGIN Phase 2b trial Safety profile of atacicept across ORIGIN program appears favorable, and comparable to placebo Completed full enrollment in the ongoing ORIGIN 3 trial Enrolling participants in the ORIGIN Extend study, which provides ORIGIN study participants with extended access to atacicept until commercial availability in their region, and captures longer-term safety and efficacy data Initiated the PIONEER trial to evaluate atacicept in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy (pMN), and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients Strengthened the Company’s financial positioning with a new credit facility of up to $500 million of term loans with existing partner Oxford Finance LLC, extending the Company’s cash runway well beyond potential commercial launch of atacicept Anticipated Upcoming Milestones Submission of a BLA for atacicept in IgAN to the U.S. FDA in Q4 2025 for accelerated approval; potential commercial launch in 2026 Presentation of the full 36-week results from the pivotal ORIGIN 3 trial expected at a medical congress in Q4 2025 Initial results from the PIONEER Phase 2 basket trial expected in Q4 2025 Pivotal ORIGIN 3 study expected to be completed in 2027 Financial Results for the Quarter Ended June 30, 2025 For the quarter ended June 30, 2025, Vera reported a net loss of $76.5 million, or a net loss per diluted share of $1.20, compared to a net loss of $33.7 million, or a net loss per diluted share of $0.62, for the quarter ended June 30, 2024. During the six months ended June 30, 2025, net cash used in operating activities was $109.2 million, compared to $58.6 million for the same period last year. Vera reported $556.8 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which combined with its undrawn debt facility, Vera believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept and beyond. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN, other autoimmune kidney diseases and lupus nephritis. The ORIGIN Phase 2b clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the ORIGIN Phase 2b clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical trials across different disease areas. About Vera Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. For more information, please 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, Vera’s plans to submit a Biologics License Application to the U.S. FDA for accelerated approval and to potentially receive FDA approval for atacicept in IgAN and launch it commercially, present full primary endpoint results from the ORIGIN 3 trial at a medical congress, obtain initial results from the PIONEER Phase 2 basket trial, and complete the ORIGIN 3 study, as well as statements regarding the timing of each such event; the ability of atacicept to advance the standard of care in IgAN and to address the unmet medical needs of IgAN patients; Vera’s ability to fund its operations through potential approval and U.S. commercial launch of atacicept; and Vera’s plans, commitments, aspirations and goals under the caption “About Vera”. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believe,” “plan,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s 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’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s 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 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. For more information, please contact: Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 [email protected] Media Contact: Debra Charlesworth Vera Therapeutics 415-854-8051 [email protected]

Related articleQuarter not tagged2025-05-06

Vera Therapeutics Provides Business Update and Reports First Quarter 2025 Financial Results

GlobeNewswire
On track to announce the primary endpoint results from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; planning for Biologics License Application (BLA) submission for atacicept accelerated approval to the U.S. FDA in 4Q 2025 Expanded atacicept development program across multiple autoimmune kidney diseases is underway BRISBANE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the first quarter ended March 31, 2025. “We are rapidly approaching a significant Vera milestone with the upcoming primary endpoint results from the pivotal atacicept ORIGIN 3 trial, and if successful, we expect this to enable a BLA submission to the FDA in the second half of this year, which may allow approval and commercial launch in 2026. If approved, we believe that atacicept has the potential to advance the standard of care in IgA nephropathy,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “The Vera team is well-positioned to build on the success of the lead atacicept development program in IgAN, with the expansion into additional potential indications in other autoimmune kidney diseases and beyond.” First Quarter 2025 and Recent Business Highlights Completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in IgAN Enrolling participants in the ORIGIN EXTEND study, which provides participants in the ORIGIN Phase 2b or Phase 3 trials with extended access to atacicept, and captures longer-term safety and efficacy data Acquired exclusive development and commercialization rights to VT-109, a novel, next generation fusion protein targeting BAFF and APRIL, with wide therapeutic potential across the spectrum of B cell mediated diseases Introduced an expanded development program for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) Major Upcoming Milestones Anticipated announcement of the primary endpoint results from the pivotal ORIGIN 3 trial in 2Q 2025 Plan to submit a Biologics License Application (BLA) for atacicept in IgAN to the U.S. F…Read full document

On track to announce the primary endpoint results from the atacicept pivotal Phase 3 ORIGIN trial in IgA Nephropathy (IgAN) in 2Q 2025; planning for Biologics License Application (BLA) submission for atacicept accelerated approval to the U.S. FDA in 4Q 2025 Expanded atacicept development program across multiple autoimmune kidney diseases is underway BRISBANE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today reported its business highlights and financial results for the first quarter ended March 31, 2025. “We are rapidly approaching a significant Vera milestone with the upcoming primary endpoint results from the pivotal atacicept ORIGIN 3 trial, and if successful, we expect this to enable a BLA submission to the FDA in the second half of this year, which may allow approval and commercial launch in 2026. If approved, we believe that atacicept has the potential to advance the standard of care in IgA nephropathy,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “The Vera team is well-positioned to build on the success of the lead atacicept development program in IgAN, with the expansion into additional potential indications in other autoimmune kidney diseases and beyond.” First Quarter 2025 and Recent Business Highlights Completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in IgAN Enrolling participants in the ORIGIN EXTEND study, which provides participants in the ORIGIN Phase 2b or Phase 3 trials with extended access to atacicept, and captures longer-term safety and efficacy data Acquired exclusive development and commercialization rights to VT-109, a novel, next generation fusion protein targeting BAFF and APRIL, with wide therapeutic potential across the spectrum of B cell mediated diseases Introduced an expanded development program for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy (PMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD) Major Upcoming Milestones Anticipated announcement of the primary endpoint results from the pivotal ORIGIN 3 trial in 2Q 2025 Plan to submit a Biologics License Application (BLA) for atacicept in IgAN to the U.S. FDA in 4Q 2025 for accelerated approval; potential PDUFA date and commercial launch in 2026 Financial Results for the Quarter Ended March 31, 2025 For the quarter ended March 31, 2025, the company reported a net loss of $51.7 million, or a net loss per share of $0.81, compared to a net loss of $28.4 million, or a net loss per diluted share of $0.56, for the quarter ended March 31, 2024. During the quarter ended March 31, 2025, net cash used in operating activities was $54.4 million, compared to $33.8 million for the same period last year. Vera reported $589.8 million in cash, cash equivalents, and marketable securities as of March 31, 2025, which the company believes to be sufficient to fund operations through potential approval and U.S. commercial launch of atacicept. About Atacicept Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis. The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN. Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications. About Vera Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. For more information, please 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, Vera’s plans to receive and report primary endpoint results in the Phase 3 ORIGIN 3 trial, to submit a BLA to the FDA, and to potentially receive a PDUFA date, receive FDA approval for atacicept in IgAN and launch it commercially, and, in each case, the timing thereof, the potential for atacicept to bring value for patients and to the change the standard of care in IgAN, if approved, and Vera’s ability to fund its operations through potential approval and U.S. commercial launch of atacicept. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “on track,” “plan,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s 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’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the 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 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. For more information, please contact: Investor Contact: Joyce Allaire LifeSci Advisors 212-915-2569 [email protected] Media Contact: Madelin Hawtin LifeSci Communications [email protected]

As of 2026-10-24 • Updated weeklySource: Earnings sourceIngestion runbook