BRISBANE, Calif., Oct. 22, 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 that it will host an investor call and webcast at 4:30 PM ET on Thursday, November 6, 2025 to review the data from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) presented at the morning plenary ses ...

BRISBANE, Calif., Oct. 17, 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 that data from the ORIGIN Phase 3 clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) will be delivered as a featured late-breaking oral presentation during the opening plenary session of the American Society of Nephrology ...

Company Overview - Vera Therapeutics is a public biotech company based in San Francisco, founded by Marshall Fordyce, who serves as the CEO [4]. - The company has been operational for about 4 years and has made significant progress with its lead product candidate, atacicept, which is an immune modulator targeting B-cell-driven diseases [4]. Product Development - Vera Therapeutics recently completed a Phase III trial for atacicept, specifically addressing IgA Nephropathy, a major unmet medical need [4]. - The company plans to file for a Biologics License Application (BLA) in the fourth quarter of this year, with expectations to be on the market by mid-next year [4]. Market Potential - The management team believes that the kidney community is on the brink of a new era in managing patients with IgA Nephropathy and other related conditions [5].

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]

Core Viewpoint - Vera Therapeutics reported a widening net loss of $76.5 million for Q2 2025, significantly exceeding analyst expectations, while also achieving revenue of $76.5 million, indicating increased spending as the company approaches regulatory filing for its lead drug candidate [1][5][6]. Financial Performance - The GAAP net loss increased by approximately 127% year-over-year, from $33.7 million in Q2 2024 to $76.5 million in Q2 2025 [2][5]. - The loss per share (GAAP) was $1.20, a significant increase from $0.62 in Q2 2024, reflecting a rapid rise in spending [6]. - Research and development expenses nearly doubled to $58.2 million from $29.3 million in Q2 2024, driven by costs associated with late-stage clinical trials and preparations for commercialization [2][6]. Business Overview - Vera Therapeutics is focused on developing therapies for serious immunological diseases, particularly Immunoglobulin A Nephropathy (IgAN), with its lead drug candidate, atacicept, designed to modify the disease course [3][9]. - The company is preparing for a pivotal Phase 3 ORIGIN trial outcome, which is crucial for a future submission to the FDA for accelerated approval [4][9]. Clinical Developments - Positive results from the ORIGIN Phase 3 trial showed a 46% reduction in proteinuria at 36 weeks, with a favorable safety profile for atacicept, reinforcing plans for a Biologics License Application (BLA) submission in Q4 2025 [7][9]. - Vera has initiated the PIONEER study to test atacicept in other kidney diseases, indicating ambitions to expand the drug's impact and revenue potential [8][12]. Strategic Initiatives - The company is building a specialized commercial team with nephrology expertise to facilitate the transition from clinical success to market adoption [10]. - Vera secured a new credit facility of up to $500 million, alongside $556.8 million in cash and equivalents, to support operations through the anticipated approval and launch of atacicept [11]. Future Outlook - Management emphasized near-term milestones, including the planned BLA submission for atacicept and expected initial results from the PIONEER trial later in the year [13][14]. - The company does not currently pay a dividend, focusing resources on advancing its clinical and commercial strategies [14].

Core Insights - Vera Therapeutics reported significant clinical results from the ORIGIN 3 trial for atacicept, showing potential as a first dual BAFF/APRIL inhibitor for IgA Nephropathy (IgAN) [2][6] - The company plans to submit a Biologics License Application (BLA) to the U.S. FDA for accelerated approval in Q4 2025, with a potential commercial launch in 2026 [2][6] Business Highlights - The ORIGIN 3 trial demonstrated a 46% reduction in proteinuria for atacicept-treated participants, achieving a statistically significant 42% reduction compared to placebo [7] - The safety profile of atacicept appears favorable and comparable to placebo, with full enrollment in the ORIGIN 3 trial completed [7] - Vera initiated the PIONEER trial to evaluate atacicept in a broader IgAN patient cohort and other autoimmune glomerular diseases [6][7] Financial Results - For Q2 2025, Vera reported a net loss of $76.5 million, compared to a net loss of $33.7 million in Q2 2024, with a net loss per diluted share of $1.20 [5] - Net cash used in operating activities for the first half of 2025 was $109.2 million, up from $58.6 million in the same period last year [5] - As of June 30, 2025, Vera had $556.8 million in cash, cash equivalents, and marketable securities, which is expected to fund operations through potential approval and commercial launch of atacicept [8] Anticipated Upcoming Milestones - BLA submission for atacicept expected in Q4 2025, with full primary endpoint results from the ORIGIN 3 trial to be presented at a medical congress in the same quarter [6][7] - Initial results from the PIONEER Phase 2 basket trial are also expected in Q4 2025, with the ORIGIN 3 study completion anticipated in 2027 [6][7]

Industry Overview - The biopharmaceuticals industry presents both exciting opportunities and significant risks for investors, with leading growth stocks often emerging from this sector due to substantial rallies following positive trial results or government drug approvals [1][2] - Many biopharma firms face constant threats of collapse due to insufficient revenue, making breakthrough developments critical for their survival [2] Investment Strategies - Investors can balance their risk tolerance by relying on Wall Street analysts who specialize in the healthcare sector, potentially identifying high-potential investments before they gain mainstream recognition [3] Company Highlights: Kymera Therapeutics - Kymera Therapeutics Inc. focuses on developing small-molecule therapeutics to selectively degrade disease-causing proteins, with positive Phase 1 trial results for its flagship drug KT-621, aimed at treating moderate to severe atopic dermatitis [4][6] - The stock forecast for Kymera indicates a 12-month price target of $59.82, representing a 25.65% upside from the current price of $47.61, with 17 out of 18 analysts rating it as a Buy [5][7] - Kymera benefits from a robust pipeline and a partnership with AI-powered biopharma developer Sanofi, along with substantial cash reserves expected to sustain operations through 2028 [7] Company Highlights: Vera Therapeutics - Vera Therapeutics Inc. specializes in treatments for immunological diseases, with its leading candidate atacicept recently completing a positive Phase 3 trial for IgAN, positioning the company for potential FDA approval and a commercial launch by 2026 [9][10] - The stock forecast for Vera suggests a 12-month price target of $65.00, indicating a 193.45% upside from the current price of $22.15, with 9 out of 10 analysts rating it as a Buy [10][12] Company Highlights: Rapport Therapeutics - Rapport Therapeutics Inc. develops medicines for neurological and psychiatric disorders, with its candidate RAP-219 showing positive trial data for refractory focal epilepsy and plans for trials in bipolar mania [13][14] - The stock forecast for Rapport indicates a 12-month price target of $32.67, representing a 191.41% upside from the current price of $11.21, with all four analysts rating it as a Buy [14][15]

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]

Group 1 - Vera Therapeutics, Inc. experienced a share price increase of over 65% during pre-market trading following the release of ORIGIN Phase 3 trial data [1] - Participants treated with atacicept for immunoglobulin A nephropathy (IgAN) showed a 46% reduction in proteinuria from baseline, with a statistically significant 42% reduction compared to placebo at week 36 (p<0.0001) [1][2] - The safety profile of atacicept was favorable and comparable to that of the placebo [2] Group 2 - Vera plans to present the trial results to the FDA soon and will submit full results to the American Society of Nephrology Kidney Week [3] - The company is targeting a potential commercial launch of atacicept in 2026 [3] - The ongoing trial will continue to evaluate kidney function changes over two years, with completion expected in 2027 [4]