Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy
Vera Therapeutics (NASDAQ: VERA) submitted a BLA through the FDA Accelerated Approval Program for atacicept to treat adults with immunoglobulin A nephropathy (IgAN) on November 7, 2025.
Submission is supported by a prespecified interim analysis of the Phase 3 ORIGIN 3 trial showing a 46% reduction from baseline in 24‑hour UPCR and a 42% reduction versus placebo at week 36 (p<0.0001). The company reports a favorable safety profile comparable to placebo. ORIGIN 3 enrolled 431 adults and remains blinded to assess eGFR over two years, with trial completion expected in 2027.
Vera Therapeutics (NASDAQ: VERA) ha presentato una BLA attraverso il programma di approvazione accelerata della FDA per atacicept per trattare gli adulti con nefropatia da IgA (IgAN) il 7 novembre 2025.
La presentazione è supportata da un'analisi intermedia preregistrata dello studio di fase 3 ORIGIN 3 che mostra una riduzione del 46% dal valore basale del UPCR a 24 ore e una riduzione del 42% rispetto al placebo alla settimana 36 (p<0,0001). La società riferisce un profilo di sicurezza favorevole, paragonabile a quello del placebo. ORIGIN 3 ha arruolato 431 adulti e resta in cieco per valutare l'eGFR per due anni, con il completamento dello studio previsto per il 2027.
Vera Therapeutics (NASDAQ: VERA) presentó una BLA a través del Programa de Aprobación Acelerada de la FDA para atacicept para tratar a adultos con nefropatía por IgA (IgAN) el 7 de noviembre de 2025.
La presentación está respaldada por un análisis interino predefinido del ensayo de fase 3 ORIGIN 3 que muestra una reducción del 46% desde los valores basales en UPCR de 24 horas y una reducción del 42% frente a placebo en la semana 36 (p<0,0001). La empresa informa un perfil de seguridad favorable comparable al placebo. ORIGIN 3 reclutó 431 adultos y permanece cegado para evaluar eGFR durante dos años, con la finalización del ensayo prevista para 2027.
Vera Therapeutics (NASDAQ: VERA) 은 2025년 11월 7일 IgAN(면역글로불린 A 신증) 환자 성인을 대상으로 atacicept를 치료하기 위한 FDA의 가속 승인 프로그램을 통한 BLA를 제출했습니다.
제출은 3상 ORIGIN 3 시험의 사전 지정된 중간 분석에 의해 뒷받침되며, 24시간 UPCR의 기저선 대비 46% 감소 및 주 36에서 위약 대비 42% 감소(p<0,0001)를 보여줍니다. 회사는 위약과 비교 가능한 유리한 안전성 프로파일을 보고합니다. ORIGIN 3은 431명의 성인을 등록했고 이 시험은 eGFR 평가를 위해 2년 동안 블라인드 상태를 유지하며, 2027년 시험완료를 목표로 합니다.
Vera Therapeutics (NASDAQ: VERA) a déposé une BLA via le programme d'approbation accélérée de la FDA pour atacicept afin de traiter les adultes atteints de néphropathie à IgA (IgAN) le 7 novembre 2025.
La soumission est soutenue par une analyse intermédiaire préspécifiée de l'essai de phase 3 ORIGIN 3 montrant une réduction de 46% par rapport à la ligne de base du UPCR sur 24 heures et une réduction de 42% par rapport au placebo à la semaine 36 (p<0,0001). La société rapporte un profil de sécurité favorable comparable à celui du placebo. ORIGIN 3 a enrôlé 431 adultes et reste en aveugle pour évaluer l'eGFR sur deux ans, l'achèvement de l'essai étant prévu en 2027.
Vera Therapeutics (NASDAQ: VERA) hat am 7. November 2025 eine BLA durch das FDA Accelerated Approval Program für atacicept zum Nachweis der Behandlung von Erwachsenen mit IgA-Nephropathie (IgAN) eingereicht.
Die Einreichung wird durch eine vordefinierte Zwischenanalyse der Phase-3-Studie ORIGIN 3 gestützt, die eine Reduktion von 46% des 24-Stunden-UPCR ab dem Ausgangswert und eine Reduktion gegenüber Placebo um 42% in Woche 36 (p<0,0001) zeigt. Das Unternehmen meldet ein günstiges Sicherheitsprofil, das dem Placebo entspricht. ORIGIN 3 rekrutierte 431 Erwachsene und bleibt verblindet, um eGFR über zwei Jahre zu bewerten, mit dem Abschluss der Studie voraussichtlich 2027.
Vera Therapeutics (NASDAQ: VERA) قدمت طلب BLA من خلال برنامج الموافقات المعجل من FDA لـ atacicept لعلاج البالغين المصابين بالاعتلال الكلوي من النوع IgA (IgAN) في 7 نوفمبر 2025.
يُستند الإرسال إلى تحليل وسيطي محدد مسبقاً لتجربة المرحلة 3 ORIGIN 3 يظهر خفضاً قدره 46% من خط الأساس في UPCR خلال 24 ساعة و خفضاً بنسبة 42% مقابل الدواء الوهمي في الأسبوع 36 (p<0,0001). وتذكر الشركة ملفاً أمانياً مفضلاً مقارنةً بالدواء الوهمي. ORIGIN 3 شملت 431 بالغا وتظل مجلوة لتقييم eGFR على مدى عامين، مع المتوقع انتهاء التجربة في 2027.
- BLA submitted to FDA via Accelerated Approval
- 46% UPCR reduction from baseline at week 36
- 42% UPCR reduction vs placebo at week 36 (p<0.0001)
- ORIGIN 3 randomized 431 adults with IgAN
- Primary result is an interim proteinuria readout, not final kidney outcome
- ORIGIN 3 continues blinded to assess eGFR through 2027
Insights
Atacicept met a strong Phase 3 interim proteinuria endpoint and a BLA was filed under Accelerated Approval.
Atacicept is a once-weekly subcutaneous dual BAFF/APRIL inhibitor designed to reduce pathogenic B-cell activity in IgA nephropathy (IgAN). The ORIGIN 3 prespecified interim analysis showed a
The regulatory and clinical path now depends on confirmatory outcomes and safety vigilance. The program reports a safety profile that "appears favorable, and comparable to placebo," but continued blinded follow-up to assess kidney function (eGFR) over two years remains ongoing. The trial is expected to complete in
Watch for three concrete items: the FDA review milestones tied to the submitted BLA, the blinded ORIGIN 3 eGFR outcomes through trial completion in
- Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgAN
- ORIGIN Phase 3 trial met its primary endpoint at the prespecified interim analysis of proteinuria reduction with
46% reduction from baseline and42% reduction vs placebo at week 36 (p<0.0001) - If approved, atacicept would be the first B cell modulator targeting both BAFF and APRIL for IgAN; potential FDA approval in 2026
BRISBANE, Calif., Nov. 07, 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 announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN).
The BLA submission for atacicept is supported by data from a prespecified interim analysis of the ORIGIN 3 trial, which met the primary endpoint of reduction in proteinuria at week 36. Participants treated with atacicept achieved a
“The submission of our first BLA marks an inflection point in our journey as a company, bringing us closer to delivering a breakthrough treatment that could change the standard of care for patients with IgAN and other autoimmune kidney diseases,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Atacicept has the potential to address the unmet medical need in IgAN as the first dual BAFF/APRIL inhibitor. We look forward to working with the U.S. regulatory authorities to bring this treatment to patients. We are energized about the path forward and thankful to the patients, caregivers, HCPs, and the Vera Therapeutics team, whose contributions made this submission possible.”
IgAN is a serious and progressive autoimmune disease of the kidney, for which there remains a high unmet need for new disease-modifying treatments that target the upstream source of the disease. In at least
ORIGIN 3 (NCT04716231) is an ongoing global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial of 431 adults with IgA nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once weekly subcutaneous injection, or placebo. The primary efficacy endpoint of the prespecified 36-week interim analysis was the change in 24-hour UPCR compared 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 and is expected to complete in 2027. For more information about ORIGIN 3, please visit http://www.clinicaltrials.gov.
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. 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 potential approval of atacicept by the FDA and related timing of such approval; Vera Therapeutics’ ability to change the standard of care for patients with IgAN and other autoimmune kidney diseases; atacicept’s potential to address the unmet medical need in IgAN; the expected completion date of ORIGIN 3; the potential for atacicept to be best-in-class; and the plans, commitments, aspirations and goals under the caption “About Vera Therapeutics”. Words such as “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
jallaire@lifesciadvisors.com
Media Contact:
Debra Charlesworth
Vera Therapeutics
415-854-8051
corporatecommunications@veratx.com
FAQ
What did Vera Therapeutics (VERA) announce on November 7, 2025 about atacicept?
What were the key ORIGIN 3 interim efficacy results for atacicept (VERA)?
When is the ORIGIN 3 Phase 3 trial for atacicept (VERA) expected to complete?
Does atacicept have an acceptable safety profile reported in ORIGIN 3?
Could atacicept become the first therapy of its kind if approved for IgAN?
What is the expected regulatory timeline mentioned for atacicept (VERA)?
