Core Insights - Vera Therapeutics, Inc. granted inducement awards to eight new employees, including non-qualified stock options for 99,000 shares and restricted stock units (RSUs) for 48,200 shares under the 2024 Inducement Plan [1][2] Group 1: Inducement Awards - The stock options have an exercise price of $20.45, which is the closing trading price on August 4, 2025 [2] - Stock options will vest over four years, with 25% vesting on the first anniversary and the remaining shares vesting monthly over the next 36 months [2] - RSUs will also vest over four years, with 25% vesting on each anniversary of August 20, 2025 [2] Group 2: Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on treatments for serious immunological diseases [3] - The lead product candidate, atacicept, is designed to block BAFF and APRIL, which are involved in autoimmune diseases like immunoglobulin A nephropathy and lupus nephritis [3] - Vera is also developing MAU868, a monoclonal antibody targeting BK virus infections, and holds global rights to atacicept and MAU868 [3]

Vera Therapeutics (VERA 1.37%), a biotechnology company developing treatments for serious immunologic diseases, released results for the quarter on August 5, 2025. The most notable news was its widening net loss to $76.5 million, or $1.20 per share (GAAP), compared to analyst expectations for a GAAP loss of $0.82 per share. While the company posted headline revenue of $76.5 million (GAAP). Results show accelerated spending as the company moves closer to a planned regulatory filing for its lead drug candidat ...

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 tha ...

Company Overview - Vera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases [3] - The company's mission is to advance treatments that target the source of immunological diseases to change the standard of care for patients [3] Product Candidates - Vera's lead product candidate is atacicept, a fusion protein administered as a subcutaneous injection once weekly, which blocks B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL) [3] - Atacicept is aimed at treating autoimmune diseases such as IgAN (Berger's disease) and lupus nephritis by reducing autoantibodies [3] - The company is also developing MAU868, a monoclonal antibody designed to neutralize BK virus (BKV) infection, which can have severe consequences in settings like kidney transplants [3] Licensing and Partnerships - Vera retains all global developmental and commercial rights to both atacicept and MAU868 [3] - The company holds an exclusive license agreement with Stanford University for a next-generation fusion protein targeting BAFF and APRIL, known as VT-109, which has wide therapeutic potential across B cell mediated diseases [3] Upcoming Events - The management team will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference from June 9 – 11, 2025 [1] - The fireside chat is scheduled for June 11, 2025, at 3:15 PM EDT, with a webcast available for 90 days [2]

Core Viewpoint - Vera Therapeutics has secured a new credit facility of up to $500 million to support its growth and development of treatments for serious immunological diseases, particularly focusing on the pivotal atacicept program for IgA nephropathy [1][2][3] Group 1: Credit Facility Details - The new credit facility replaces an existing $50 million facility and includes an initial funding of $75 million expected on June 4, 2025 [1] - The refinancing reduces interest expenses significantly, lowering the borrowing cost by 320 basis points, with a new interest rate of 1-month SOFR plus 4.95%, subject to a SOFR floor of 3.75% [5] - The facility provides an additional $450 million of discretionary incremental capacity available in five tranches, allowing Vera to draw funds based on specific milestones and approvals [5] Group 2: Strategic Implications - The new credit facility enhances Vera's financial flexibility, allowing for an extended interest-only period of up to 42 months and no principal payments required in 2026 [5] - The refinancing is expected to improve Vera's ability to manage its capital structure efficiently and support the commercial launch of atacicept [2][5] - Vera aims to submit a Biologics License Application (BLA) to the FDA in Q4 2025, with potential approval and commercial launch of atacicept in 2026 [2][3] Group 3: Company Overview - Vera Therapeutics is focused on developing transformative treatments for serious immunological diseases, with its lead product candidate being atacicept, which targets B-cell Activating Factor (BAFF) and APRIL [4] - The company holds an exclusive license agreement with Stanford University for a next-generation fusion protein, VT-109, aimed at treating B cell-mediated diseases [4][6] - Vera is also developing MAU868, a monoclonal antibody designed to neutralize BK virus infections, which can have severe consequences in kidney transplant settings [4][6]

Core Insights - Vera Therapeutics announced that the ORIGIN Phase 3 trial of atacicept for immunoglobulin A nephropathy (IgAN) met its primary endpoint, demonstrating significant efficacy in reducing proteinuria [1][7]. Efficacy Results - Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria, measured by the 24-hour urine protein-to-creatinine ratio (UPCR), and a 42% reduction compared to placebo at week 36 (p<0.0001) [2][7]. - Other prespecified endpoints showed results consistent with or better than those observed in the ORIGIN Phase 2b trial [2][7]. Safety Profile - The safety profile of atacicept was favorable and comparable to that of the placebo [2][7]. Regulatory Plans - Vera plans to share these results with the FDA and intends to submit a Biologics License Application (BLA) for atacicept in IgAN in the fourth quarter of 2025, potentially allowing for US approval and commercial launch in 2026 [4][7]. Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study involving 431 adults with IgAN, with participants receiving either atacicept 150 mg or placebo [5][7]. - The trial continues to evaluate changes in kidney function over two years, with completion expected in 2027 [5][7]. Company Vision - Vera Therapeutics aims to advance the standard of care in IgAN and other autoimmune kidney diseases, aspiring to evolve kidney medicine practices [4][12].

"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-position ...

Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Enrollment and Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - Participants are randomized to receive either atacicept 150 mg or placebo via self-administered weekly subcutaneous injections for a 104-week double-blind period, followed by a 52-week open-label extension [2] Efficacy and Safety Data - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, with a key secondary endpoint assessing kidney function via estimated glomerular filtration rate (eGFR) over 104 weeks [3] - The Phase 2b ORIGIN trial demonstrated significant reductions in proteinuria and stabilization of eGFR, supporting the efficacy of atacicept [6] Future Plans and Market Position - The company plans to submit a BLA for atacicept in the second half of 2025, with a potential commercial launch in 2026 [2][8] - Vera Therapeutics retains all global developmental and commercial rights to atacicept and is also developing MAU868, a monoclonal antibody targeting BK virus [9]

Core Insights - Vera Therapeutics has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept for IgA Nephropathy (IgAN) with a total of 431 participants, marking a significant milestone towards potential FDA approval [1][2] - The company anticipates primary efficacy endpoint data from the trial within the current quarter, supporting a planned Biologics License Application (BLA) for accelerated approval to the U.S. FDA in the second half of 2025 [2][8] - Atacicept has received FDA Breakthrough Therapy Designation, indicating its potential to significantly improve treatment outcomes for IgAN patients compared to existing therapies [7] Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases, with atacicept as its lead product candidate [9] - Atacicept is a recombinant fusion protein that targets B-cell activating factors, aiming to reduce autoantibody production associated with autoimmune diseases like IgAN and lupus nephritis [5][9] - The company is also developing MAU868, a monoclonal antibody for BK virus infections, and holds an exclusive license for a next-generation fusion protein targeting BAFF and APRIL [9] Clinical Trial Details - The ORIGIN 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria [2][3] - The primary efficacy endpoint is the change in proteinuria measured by urine protein to creatinine ratio (UPCR) through 36 weeks, while the key secondary endpoint assesses kidney function via estimated glomerular filtration rate (eGFR) through 104 weeks [3] - The ORIGIN Phase 2b trial previously demonstrated significant reductions in proteinuria and stabilization of kidney function, reinforcing the potential of atacicept as a best-in-class therapy for IgAN [6]

Core Insights - Vera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases [3] - The company will participate in the TD Cowen 45th Annual Health Care Conference from March 3 – 5, 2025, including a fireside chat and one-on-one investor meetings [1][2] Company Overview - Vera's mission is to advance treatments targeting the source of immunological diseases to change the standard of care for patients [3] - The lead product candidate, atacicept, is a fusion protein administered subcutaneously once weekly, designed to block B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are involved in autoimmune diseases like IgAN and lupus nephritis [3] - Vera is also developing MAU868, a monoclonal antibody aimed at neutralizing BK virus infections, particularly in kidney transplant settings [3] - The company retains all global developmental and commercial rights to both atacicept and MAU868, and has an exclusive license agreement with Stanford University for a next-generation fusion protein, VT-109, targeting BAFF and APRIL [3]