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Vera Therapeutics, Inc. (Nasdaq: VERA) is a late clinical-stage biotechnology company committed to developing and commercializing pioneering treatments for patients with serious immunological diseases. The company's primary product candidate, atacicept, is a fusion protein designed for subcutaneous injection once weekly. Atacicept blocks both B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), thereby inhibiting the stimulation of B cells and plasma cells that produce autoantibodies contributing to autoimmune diseases such as IgA nephropathy (IgAN) and lupus nephritis.
One of the company's significant achievements is the development of atacicept, which has shown promising results in clinical trials. The Phase 2b ORIGIN clinical trial demonstrated atacicept's potential to modify disease progression in IgAN patients, with data showing consistent and sustained reductions in Gd-IgA1, hematuria, and UPCR, along with stable eGFR over 72 weeks. The ongoing pivotal Phase 3 ORIGIN 3 trial aims to further evaluate atacicept's efficacy and safety in a larger cohort of IgAN patients.
Additionally, Vera is advancing MAU868, a monoclonal antibody designed to neutralize BK virus (BKV) infections, which are particularly problematic in kidney transplant patients. Vera retains global developmental and commercial rights to both atacicept and MAU868, positioning the company well in the biopharmaceutical market.
Financially, Vera reported a net loss of $28.4 million for the quarter ended March 31, 2024, with sufficient cash reserves to fund operations through the potential approval and U.S. launch of atacicept. The company has also announced various strategic partnerships and funding rounds to support its ambitious research and development goals.
Recently, Vera Therapeutics received FDA Breakthrough Therapy Designation for atacicept in IgAN, indicating the drug's potential to substantially improve kidney function compared to existing therapies. This designation expedites the development and review process, bringing hope to patients suffering from this debilitating disease.
For more information about Vera Therapeutics and its clinical trials, please visit the company's website at www.veratx.com.
Vera Therapeutics, a late-stage biotechnology company, announced its participation in two investor conferences. The Piper Sandler 34th Annual Healthcare Conference will feature a presentation on November 29, 2022, from 9:50 to 10:10 AM ET. Additionally, a Fireside Chat is scheduled for December 1, 2022, at the 5th Annual Evercore ISI HealthCONx Conference from 12:10 to 12:30 PM ET. Both sessions will be webcasted, and replays will be accessible for 90 days. Vera is focused on treatments for immunological diseases and is advancing its lead candidate, atacicept.
Vera Therapeutics, Inc. (Nasdaq: VERA) announced a key opinion leader webinar on November 28, 2022, focusing on IgA nephropathy (IgAN), a leading cause of kidney failure. Dr. Jonathan Barratt will discuss IgAN's pathogenesis and the clinical data for atacicept, a treatment showing promise in reducing immune complex levels in patients. IgAN affects around 400,000 patients in the U.S., EU, and Japan, with many progressing to end-stage renal disease. Vera expects to present topline results from its Phase 2b ORIGIN trial in early 2023 and potentially initiate a Phase 3 trial later that year.
Vera Therapeutics reported its Q3 2022 financial results, showing a net loss of $24.7 million, or $0.91 per diluted share, a significant increase from a net loss of $7.6 million in Q3 2021. The company has a strong balance sheet with $114.4 million in cash and cash equivalents, allowing operations to be funded into Q2 2024. Vera initiated the Phase 3 COMPASS trial for atacicept in lupus nephritis and announced topline data from the Phase 2b ORIGIN trial in IgA nephropathy expected in early Q1 2023. A positive interim analysis of MAU868 demonstrated safety and effectiveness in treating kidney transplant patients.
Vera Therapeutics (Nasdaq: VERA) presented new data on its therapies atacicept and MAU868 at the ASN Kidney Week 2022. Analysis from the Phase 2a JANUS trial indicates atacicept significantly reduced immune complex levels in patients with IgA nephropathy (IgAN), marking it as the first treatment to target key factors in IgAN pathogenesis. Additionally, the Phase 2 trial of MAU868 demonstrated tolerability and clinically meaningful antiviral activity against BK virus in kidney transplant patients. Vera anticipates presenting topline results from its Phase 2b ORIGIN trial for atacicept in early 2023.
Vera Therapeutics (Nasdaq: VERA) announced the presentation of new clinical data on two product candidates, MAU868 and atacicept, at the American Society of Nephrology Kidney Week 2022 Annual Meeting, held November 3-6, 2022. The oral presentation on MAU868 will detail final results from its Phase 2 trial addressing BK Viremia in kidney transplant recipients, scheduled for November 5, while the poster presentation on atacicept will analyze data from the Phase 2a JANUS clinical trial for IgA nephropathy on the same day.
Vera Therapeutics, a late-stage biotechnology company focused on immunological diseases, announced participation in two key conferences: the Morgan Stanley Global Healthcare Conference and the HC Wainwright 24th Annual Global Investment Conference. Both events will feature management presentations as well as one-on-one meetings. The Morgan Stanley conference is scheduled for September 12-14, 2022, with a presentation at 3:40 PM EDT on September 12. The HC Wainwright conference will also take place on September 12-14, with a presentation on September 13 at 3:00 PM EDT. Replays will be available for 90 days on their website.
Vera Therapeutics (VERA) reported significant developments and financial results for Q2 2022. The company completed enrollment for the Phase 2b ORIGIN trial of atacicept in IgA nephropathy, with topline data expected in early Q1 2023. Positive interim results for MAU868 in kidney transplant patients were presented at the American Transplant Congress, with plans for further clinical trials. As of June 30, 2022, Vera held approximately $131.9 million in cash and equivalents and has access to a $45 million credit facility, expected to fund operations through Q2 2024.
Vera Therapeutics, a late-stage biotechnology company focused on immunological diseases, will present at the 13th Annual Wedbush PacGrow Healthcare Conference on August 10, 2022, from 12:00 – 12:30 PM ET. This virtual conference will also include one-on-one investor meetings. The company's lead product candidate, atacicept, targets autoimmune diseases like IgA nephropathy and lupus nephritis. A live audio webcast will be available, with a replay accessible for 90 days afterward. For more information, visit www.veratx.com.
Vera Therapeutics has completed patient enrollment for the Phase 2b ORIGIN clinical trial of atacicept, aimed at treating IgA nephropathy (IgAN), a serious kidney disease. The trial involves 115 patients who are at high risk of disease progression despite existing treatments. Topline results are expected in Q4 2022. Atacicept is designed to reduce proteinuria, a key marker of kidney damage. This milestone comes as IgAN has no approved treatments, affecting an estimated 400,000 patients in the U.S., EU, and Japan.
Vera Therapeutics (Nasdaq: VERA) announced positive interim results from a Phase 2 trial of MAU868, a first-in-class monoclonal antibody targeting BK Virus (BKV) in kidney transplant recipients. Presented at the American Transplant Congress 2022, data showed MAU868 was well tolerated and demonstrated significant antiviral activity, with 55% of patients achieving a prespecified reduction in BK plasma viral load. As there are currently no approved treatments for BKV, these results support the further development of MAU868 as a promising therapeutic option for affected patients.
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