VERA

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...

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...

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...

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...

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...

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...