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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 (NASDAQ: VERA) announces partnership with University of Michigan on the NEPTUNE Match project and PIONEER study. NEPTUNE Match, a consortium of over 30 North American academic centers, will connect nephrotic syndrome patients with clinical trials based on their molecular disease characteristics. The PIONEER study expands atacicept development into multiple autoimmune kidney indications, including primary membranous nephropathy (pMN), focal segmental glomerulosclerosis (FSGS), and minimal change disease (MCD). The collaboration aims to identify and enroll eligible participants with specific antibodies for the PIONEER study, with initial data expected in 2025.
Vera Therapeutics (Nasdaq: VERA), a late clinical-stage biotechnology company developing treatments for serious immunological diseases, has announced its management team's participation in two upcoming investor conferences. The team will participate in:
1. The Guggenheim Securities Healthcare Innovation Conference on November 13, 2024, at 9:30am EST in Boston, MA, featuring a fireside chat and one-on-one meetings.
2. The 7th Annual Evercore ISI HealthCONx Conference on December 5, 2024, at 7:55am EST in Coral Gables, FL, also including a fireside chat and one-on-one meetings.
Webcasts will be available for both events, with replays accessible for 90 days through Vera's website.
Vera Therapeutics (Nasdaq: VERA), a late clinical-stage biotechnology company developing treatments for immunological diseases, has announced its management team's participation in upcoming investor conferences. The company will participate in two events:
1. The Guggenheim Securities Healthcare Innovation Conference on November 13, 2024, at 9:30am EST in Boston, MA, featuring a fireside chat and one-on-one meetings.
2. The 7th Annual Evercore ISI HealthCONx Conference on December 5, 2024, at 7:55am EST in Coral Gables, FL, also including a fireside chat and one-on-one meetings.
Webcasts will be available for both events with 90-day replay access through Vera's website.
Vera Therapeutics (NASDAQ: VERA) reported key developments in Q3 2024, highlighting positive 96-week eGFR stabilization data from the ORIGIN Phase 2b trial of atacicept in IgAN. The company completed enrollment for the pivotal Phase 3 ORIGIN 3 trial, with topline data expected in Q2 2025. Vera reported a Q3 net loss of $46.6 million ($0.85 per share), compared to $20.1 million ($0.45 per share) in the previous year. The company strengthened its financial position with a $345 million equity offering and reported $353.3 million in cash and equivalents, which is expected to fund operations through potential approval and commercial launch of atacicept.
Vera Therapeutics, a late clinical-stage biotechnology company, has announced the pricing of its public offering of 7,142,858 shares of Class A common stock at $42.00 per share. The offering is expected to generate approximately $300.0 million in gross proceeds before deducting underwriting costs and expenses. The company has granted underwriters a 30-day option to purchase up to an additional 1,071,428 shares. The offering is expected to close on October 31, 2024, with J.P. Morgan, Goldman Sachs, Evercore ISI, and Cantor serving as joint book-running managers.
Vera Therapeutics (VERA), a late clinical-stage biotechnology company, has announced plans for a $300 million public offering of Class A common stock. The company will grant underwriters a 30-day option to purchase up to an additional 15% of shares. J.P. Morgan, Goldman Sachs & Co. , Evercore ISI and Cantor are acting as joint book-running managers. The offering will be made through an automatic shelf registration statement on Form S-3 filed with the SEC on October 28, 2024.
Vera Therapeutics (NASDAQ: VERA) announced 96-week data from its ORIGIN Phase 2b trial of atacicept in IgA nephropathy (IgAN), showing stabilized kidney function. The results, presented at ASN Kidney Week 2024, demonstrated -66% reduction in Gd-IgA1, 75% resolution of hematuria, -52% reduction in proteinuria, and a mean annualized eGFR slope of -0.6 mL/min/1.73m2/year. The trial maintained a 90% completion rate with a favorable safety profile. The company expects topline results from Phase 3 ORIGIN 3 trial in Q2 2025, with planned BLA submission later that year.
Vera Therapeutics (Nasdaq: VERA) announced inducement awards granted to seven new employees on October 2, 2024. The awards, approved by the Compensation Committee under Nasdaq Listing Rule 5635(c)(4), include:
1. Non-qualified stock options to purchase 125,000 shares of Class A common stock
2. Restricted stock units (RSUs) for 62,500 shares of Class A common stock
The stock options have an exercise price of $41.75 per share, equal to Vera's closing price on October 2, 2024. They will vest over four years, with 25% vesting on the first anniversary and the remainder monthly over 36 months. The RSUs will vest over four years, with 25% vesting annually starting November 20, 2024. Both awards are subject to continued employment and the terms of the Inducement Plan and applicable award agreements.
Vera Therapeutics (Nasdaq: VERA) announced that long-term results from the ORIGIN Phase 2b clinical trial of atacicept for IgAN treatment will be presented at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego, from October 23 to 27. The presentation will be delivered by Dr. Jonathan Barratt on October 26. Additionally, two informational posters describing the ORIGIN Phase 3 and ORIGIN Extend trials will be presented by Dr. Richard Lafayette on October 25.
Vera will also host an in-person and virtual R&D Day in New York on October 2, 2024, featuring experts Dr. Jonathan Barratt, Dr. Richard Lafayette, and Dr. Brad Rovin, who will discuss Vera's expanded atacicept R&D activities.
Vera Therapeutics (Nasdaq: VERA) announced an expansion of its development pipeline for atacicept, its lead asset. The company plans to extend the drug's application beyond IgA nephropathy (IgAN) to other autoimmune kidney diseases. Key points include:
1. ORIGIN Extend: A study providing extended access to atacicept for ORIGIN participants, starting Q4 2024.
2. PIONEER Study: Planned for 2025, evaluating atacicept in expanded IgAN populations and other autoimmune glomerular diseases.
3. The combined peak prevalence of target diseases in the US is estimated at ~230,000.
4. 96-week data from the Phase 2b ORIGIN study will be presented at the American Society of Nephrology Kidney Week 2024.