Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for Atacicept for Treatment of Adults with IgA Nephropathy

Rhea-AI Summary

Vera Therapeutics (NASDAQ: VERA) announced the U.S. FDA accepted its BLA for atacicept in adults with immunoglobulin A nephropathy (IgAN) and granted Priority Review with a PDUFA target action date of July 7, 2026.

The submission used the Accelerated Approval Program and follows Breakthrough Therapy designation. A prespecified interim analysis from the ORIGIN 3 trial showed atacicept reduced proteinuria by 46% from baseline and by 42% versus placebo (p<0.0001) at week 36. Results were presented at ASn Kidney Week and published in the New England Journal of Medicine on November 6, 2025. If approved, atacicept could be offered as a once-weekly subcutaneous autoinjector for at-home use.

Positive

• Priority Review assigned with PDUFA date July 7, 2026
• ORIGIN 3 trial: 46% proteinuria reduction from baseline at week 36
• ORIGIN 3 trial: 42% reduction vs placebo (p<0.0001) at week 36
• Breakthrough Therapy designation supports expedited pathway
• BLA submitted via Accelerated Approval pathway
• Potential once-weekly autoinjector for at-home administration

Negative

• None.

News Market Reaction

+4.64%

19 alerts

+4.64% News Effect

+18.5% Peak in 9 min

+$145M Valuation Impact

$3.26B Market Cap

5K Volume

On the day this news was published, VERA gained 4.64%, reflecting a moderate positive market reaction. Argus tracked a peak move of +18.5% during that session. Our momentum scanner triggered 19 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $145M to the company's valuation, bringing the market cap to $3.26B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

PDUFA date: July 7, 2026 Proteinuria reduction: 46% Placebo comparison: 42% reduction +5 more

8 metrics

PDUFA date July 7, 2026 FDA priority review target action date for atacicept BLA in IgAN

Proteinuria reduction 46% Reduction from baseline in proteinuria at week 36 in ORIGIN 3

Placebo comparison 42% reduction Clinically meaningful UPCR reduction vs placebo at week 36

P-value p<0.0001 Statistical significance for UPCR reduction vs placebo at week 36

Assessment timepoint 36 weeks Primary endpoint measurement timing in ORIGIN 3 trial

Injection frequency Once-weekly At-home subcutaneous atacicept administration schedule

ESKD risk At least 50% Share of IgAN patients progressing to end-stage kidney disease or failure

UPCR measure 24-hour UPCR Urine protein-to-creatinine ratio used to assess proteinuria

Market Reality Check

Price: $42.96 Vol: Volume 1,541,152 vs 20-da...

normal vol

$42.96 Last Close

Volume Volume 1,541,152 vs 20-day average 1,442,301 (relative volume 1.07x) normal

Technical Price $46.52 trading above 200-day MA at $27.37, indicating a pre-news uptrend

Peers on Argus

VERA fell 1.17% while close peers showed mixed moves, from -7.79% (ARDX) to +3.4...

VERA fell 1.17% while close peers showed mixed moves, from -7.79% (ARDX) to +3.47% (VRDN), indicating a stock-specific reaction rather than a broad biotech move.

Historical Context

5 past events · Latest: Dec 09 (Negative)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 09	Equity offering priced	Negative	-0.8%	Underwritten public offering of Class A shares at $42.50 per share.
Dec 08	Equity offering planned	Negative	+0.3%	Proposed $200 million Class A common stock offering announcement.
Dec 05	Inducement grants	Neutral	+0.3%	Stock options and RSUs granted to seven new employees under inducement plan.
Nov 26	Board appointment	Positive	+13.3%	Veteran biotech executive added to board as company prepares atacicept launch.
Nov 24	Investor conferences	Neutral	+2.7%	Participation in early December healthcare investor conferences and webcasts.

Pattern Detected

Recent news included capital raises and governance changes, with the equity offering drawing a mild negative reaction but the board appointment linked to atacicept launch preparations seeing a strong positive move.

Recent Company History

Over the past few months, Vera reported several notable events. An November 6, 2025 update highlighted positive Phase 3 ORIGIN data for atacicept in IgA nephropathy. Late November brought a new director appointment and related compensation, followed by investor conference participation. In December, Vera announced a proposed and then priced equity offering and inducement equity grants to new employees. Today’s FDA priority review and PDUFA date build directly on the prior clinical success and the capital raise intended to support a potential atacicept launch.

Market Pulse Summary

This announcement details FDA priority review for atacicept’s BLA in IgA nephropathy, with a PDUFA t...

Analysis

This announcement details FDA priority review for atacicept’s BLA in IgA nephropathy, with a PDUFA target date of July 7, 2026. The filing is supported by ORIGIN 3 data showing a 46% proteinuria reduction and a statistically robust p<0.0001 vs placebo. Investors may weigh this alongside prior Phase 3 results, recent equity offerings to fund commercialization, insider activity, and upcoming regulatory milestones as they track the path toward a potential launch.

Key Terms

priority review, biologics license application, pdufa, accelerated approval program, +4 more

8 terms

priority review regulatory

"was accepted for Priority Review by the U.S. Food and Drug Administration"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

biologics license application regulatory

"announced the atacicept Biologics License Application (BLA) for the treatment"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

pdufa regulatory

"was assigned a Prescription Drug User Fee Act (PDUFA) target action date"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

accelerated approval program regulatory

"The BLA, which was submitted using the Accelerated Approval Program, was assigned"

A regulatory pathway that lets a drug or treatment reach the market sooner for serious or life‑threatening conditions based on early signs of benefit (such as lab tests or short‑term results) rather than long‑term proof. It matters to investors because it can accelerate revenue and competitive advantage but carries higher risk: the approval depends on follow‑up studies, and if those fail regulators can withdraw the approval, which can sharply affect a company’s value.

iga nephropathy medical

"for the treatment of adults with immunoglobulin A nephropathy (IgAN) was accepted"

A kidney disease caused when deposits of the antibody called IgA collect in the tiny filters of the kidney, gradually reducing their ability to clear waste — like grit building up in a water filter. It matters to investors because it creates demand for diagnostics, drugs and long‑term care, drives clinical trial activity and regulatory decisions, and can influence the financial outlook of companies in pharma, biotech, medical devices and health insurance.

b cell modulator medical

"first B cell modulator targeting both BAFF and APRIL for IgAN"

A B cell modulator is a drug or therapy that changes the activity of B cells, a type of immune cell that makes antibodies; think of it as a thermostat that turns B cell responses up, down, or reshapes how they work. It matters to investors because these therapies can treat autoimmune diseases and certain cancers, so their safety, effectiveness, trial results and regulatory approval directly affect a company’s market potential, risk profile and valuation.

baff medical

"dual targeting of BAFF and APRIL, which we believe could advance"

BAFF is a naturally occurring protein that helps certain immune cells (B cells) grow, survive and produce antibodies; think of it as a fertilizer that encourages those cells to multiply. It matters to investors because drugs that block or enhance BAFF can change the course of autoimmune diseases or B‑cell cancers, so clinical results, approvals or partnerships tied to BAFF-related therapies can strongly affect a biotech company’s value and prospects.

april medical

"dual targeting of BAFF and APRIL, which we believe could advance"

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

AI-generated analysis. Not financial advice.

• FDA assigned PDUFA target action date of July 7, 2026.
• If approved, atacicept would be the first B cell modulator targeting both BAFF and APRIL for IgAN.
• Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgAN.
  

BRISBANE, Calif., Jan. 07, 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 announced the atacicept Biologics License Application (BLA) for the treatment of adults with immunoglobulin A nephropathy (IgAN) was accepted for Priority Review by the U.S. Food and Drug Administration (FDA). The BLA, which was submitted using the Accelerated Approval Program, was assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026. If approved, atacicept could offer patients an autoinjector for at-home self-administration of a once-weekly subcutaneous injection.

“Atacicept offers a distinct approach through dual targeting of BAFF and APRIL, which we believe could advance the standard of care in IgAN, if approved,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “FDA’s Priority Review designation reinforces the need for new therapies that can reshape the IgAN treatment landscape. We remain committed to working with the FDA to facilitate a thorough review of the BLA. Our team is focused on bringing a potential treatment to patients with the urgency they deserve.”

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 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. The safety profile of atacicept across the ORIGIN program appears favorable, and comparable to placebo. Results of the interim analysis were presented as a late-breaking oral presentation at the opening plenary session of the American Society of Nephrology Kidney Week meeting and published in a manuscript in the New England Journal of Medicine on November 6.¹

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 50% of patients, IgAN can lead to end-stage kidney disease or kidney failure, which has considerable morbidity and impact on patients’ lives. Atacicept is being developed as an at-home self-administered subcutaneous once-weekly injection that inhibits B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), cytokines that drive B-cell production of autoantibodies associated with IgAN and potentially other autoimmune kidney diseases.

1. Lafayette R, et al. N Engl J Med. 2025 Nov 6. doi: 10.1056/NEJMoa2510198. Online ahead of print.
   

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. 

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. ORIGIN 3 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. 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 
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 B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including immunoglobulin A nephropathy (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.

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; the distinct approach of atacicept; atacicept's ability to advance the standard of care in IgAN; the strength of Vera Therapeutics’ clinical evidence; the timing of expected results 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 “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 is the FDA PDUFA date for Vera Therapeutics' atacicept (VERA)?

The FDA assigned a PDUFA target action date of July 7, 2026 for atacicept.

What were the ORIGIN 3 trial proteinuria results for atacicept (VERA) at week 36?

ORIGIN 3 reported a 46% reduction from baseline and a 42% reduction versus placebo (p<0.0001) at week 36.

Has the FDA given any special designations to atacicept from Vera Therapeutics (VERA)?

Yes, atacicept received Breakthrough Therapy designation and the BLA was filed under the Accelerated Approval program.

If approved, how would atacicept (VERA) be administered to patients with IgAN?

If approved, atacicept could be offered as a once-weekly subcutaneous autoinjector for at-home self-administration.

Where were the atacicept ORIGIN 3 results published and presented?

Results were presented as a late-breaking oral at the American Society of Nephrology Kidney Week and published in the New England Journal of Medicine on November 6, 2025.

What mechanism does atacicept (VERA) target in IgA nephropathy?

Atacicept dual-targets the cytokines BAFF and APRIL to inhibit B-cell production of autoantibodies associated with IgAN.