Vera Therapeutics(VERA)
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Vera Therapeutics Acquires Global Rights to Novel, Next Generation Dual BAFF/APRIL Inhibitor
Globenewswire· 2025-01-13 12:00
Company Overview - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases [2] - The company's mission is to advance treatments targeting the source of immunological diseases to change the standard of care for patients [2] - Vera's lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both BAFF and APRIL, which stimulate B cells to produce autoantibodies contributing to autoimmune diseases like IgAN and lupus nephritis [2] - The company is also developing MAU868, a monoclonal antibody designed to neutralize BK virus (BKV) infection, particularly in kidney transplant settings [2] - Vera retains all global developmental and commercial rights to atacicept and MAU868 [2] Strategic Development - Vera announced an exclusive license agreement with Stanford University for VT-109, a novel next-generation fusion protein targeting BAFF and APRIL, with wide therapeutic potential across B cell mediated diseases [1] - This agreement is part of Vera's lifecycle management strategy to expand and extend its leadership position in B cell modulation [4] - The company plans to leverage its research, translational medicine, clinical development, and commercial expertise to advance VT-109 [4] - The agreement enables Vera to develop and market VT-109 in return for undisclosed upfront and milestone payments [4] Leadership Perspective - Marshall Fordyce, MD, Founder and CEO of Vera Therapeutics, emphasized the potential of VT-109 to transform the treatment of patients with B cell mediated diseases [4] - The transaction reflects Vera's commitment to improving outcomes for patients with severe autoimmune diseases [4]
Vera Therapeutics to Participate in the 43rd Annual J.P. Morgan Healthcare Conference
Globenewswire· 2025-01-07 21:05
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 targeting the source of immunological diseases to change the standard of care for patients [3] Product Pipeline - 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) infections, particularly in kidney transplant settings [3] - Vera retains all global developmental and commercial rights to both atacicept and MAU868 [3] Upcoming Events - The management team will present at the 43rd Annual J.P. Morgan Healthcare Conference from January 12 to 16, 2025, and will participate in one-on-one investor meetings [1] - The presentation is scheduled for January 13, 2025, at 4:30 PM PST, with a webcast available for viewing [2]
Wall Street Analysts Think Vera Therapeutics (VERA) Could Surge 27.26%: Read This Before Placing a Bet
ZACKS· 2024-11-11 16:00
Core Viewpoint - Vera Therapeutics, Inc. (VERA) has seen a 12.6% increase in share price over the past four weeks, closing at $48.09, with a potential upside of 27.3% based on Wall Street analysts' mean price target of $61.20 [1] Price Targets and Estimates - The mean estimate consists of 10 short-term price targets with a standard deviation of $23.03, indicating variability among analysts; the lowest estimate suggests a 48% decline to $25, while the highest predicts a 122.5% increase to $107 [2] - Analysts' price targets can be misleading, as empirical research shows they rarely indicate actual stock price movements [5] - A low standard deviation in price targets suggests a high degree of agreement among analysts regarding the stock's price direction, serving as a starting point for further research [7] Earnings Estimates - Analysts have shown increasing optimism about VERA's earnings prospects, with a strong consensus in revising EPS estimates higher, which correlates with potential stock price increases [9] - The Zacks Consensus Estimate for the current year has risen by 0.7% over the past month, with one estimate increasing and no negative revisions [10] - VERA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating potential upside [11]
Vera Therapeutics to Participate at Upcoming Investor Conferences
GlobeNewswire News Room· 2024-11-08 13:00
BRISBANE, Calif., Nov. 08, 2024 (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 the Company’s management team will present and participate in one-on-one meetings at upcoming investor conferences. Investor Conference Details: Guggenheim Securities Healthcare Innovation ConferenceFormat: Fireside Chat and 1x1sWebcast ...
Vera Therapeutics(VERA) - 2024 Q3 - Quarterly Report
2024-11-07 21:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40407 Vera Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 81-2744449 (State or other ju ...
Vera Therapeutics Announces Pricing of Public Offering of Class A Common Stock
GlobeNewswire News Room· 2024-10-30 00:21
BRISBANE, Calif., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. ("Vera"), a late clinicalstage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced the pricing of an underwritten public offering of 7,142,858 shares of its Class A common stock at a price to the public of $42.00 per share. The gross proceeds to Vera from the offering, before deducting underwriting discounts and commissions and esti ...
Vera Therapeutics (VERA) Update / Briefing Transcript
2024-10-28 13:02
Summary of Vera Therapeutics Virtual Investor Event Company Overview - **Company**: Vera Therapeutics - **Lead Product**: Atacicept, a dual B cell modulator in Phase 3 for IgA nephropathy (IgAN) with potential applications in various autoimmune diseases [4][5][6] Industry Context - **Disease Focus**: IgA nephropathy (IgAN), an immune complex-mediated kidney disease leading to inflammation and kidney failure, particularly in young adults [10][29] - **Market Opportunity**: Estimated prevalence of IgAN in the US is around 160,000 patients, with potential to expand treatment to over 200,000 patients with autoimmune kidney diseases [8][5] Key Clinical Data - **Phase 2b Study Results**: Long-term data from the Origin Phase 2b study presented at the American Society of Nephrology's Kidney Week [2][10] - **Efficacy**: Atacicept demonstrated a significant reduction in immune complexes, proteinuria, and stabilization of kidney function (GFR) over 96 weeks [4][19][25] - **GFR Stabilization**: Annualized loss of kidney function was 0.6 mL/min/year, compared to an average of 6 mL/min/year in placebo-treated populations [20][21] - **Safety Profile**: Atacicept was well tolerated with over 90% retention rate in the open-label extension phase [24][50] Regulatory and Commercial Strategy - **FDA Designation**: Atacicept received breakthrough designation from the FDA, with plans for a BLA submission in the second half of 2025 and a projected commercial launch in 2026 [5][30] - **Intellectual Property**: Anticipated biologics exclusivity protection through 2038 in the US, with strategies to extend the lifecycle of Atacicept [6][8] Competitive Landscape - **Comparison with Other Treatments**: Atacicept's mechanism targets the production of pathogenic IgA, contrasting with traditional treatments like steroids and complement inhibitors that do not address the root cause of IgAN [40][59] - **Patient-Centric Approach**: Atacicept allows for at-home self-administration, enhancing patient compliance and quality of life compared to in-clinic treatments [33][65] Future Directions - **Expansion of Clinical Trials**: Initiation of two new studies (Origin Extend and PIONEER) to explore Atacicept's efficacy in broader populations and additional autoimmune diseases [30][72] - **Long-term Monitoring**: Ongoing assessment of safety, particularly regarding infection risks and potential hypogammaglobulinemia associated with long-term B cell modulation [90][91] Financial Position - **Cash Reserves**: Vera Therapeutics reported a strong financial position with approximately $3.38 billion in cash [8] Conclusion - **Transformative Potential**: Atacicept represents a significant advancement in the treatment of IgAN and potentially other autoimmune diseases, with promising clinical data supporting its efficacy and safety [26][25]
Vera Therapeutics Announces Late-Breaking Oral Presentation of ORIGIN Phase 2b Long-term Results at the American Society of Nephrology Kidney Week 2024
GlobeNewswire News Room· 2024-10-02 10:30
Clinical Trial Updates - Long-term results from the ORIGIN Phase 2b clinical trial of atacicept for IgAN treatment will be presented at ASN Kidney Week 2024, alongside two informational posters detailing the ORIGIN Phase 3 and ORIGIN Extend trials [1] - The ORIGIN Phase 2b trial met its primary and key secondary endpoints, showing statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR compared to placebo through 36 weeks [6] - Atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR through 72 weeks, reflecting a profile consistent with the general population without IgAN [6] Upcoming Events - An in-person and virtual R&D Day will be held in New York on October 2, 2024, featuring discussions on expanded atacicept R&D activities with key opinion leaders and the company's management team [3] - The ASN Kidney Week 2024 presentations include a late-breaking oral presentation on the ORIGIN Phase 2b study and two informational posters on the ORIGIN Phase 3 and ORIGIN Extend trials [1][2] Product and Pipeline Overview - Atacicept is a fusion protein that blocks BAFF and APRIL, targeting B cells and plasma cells to reduce autoantibodies in autoimmune diseases like IgAN and lupus nephritis [4][5] - The product has received FDA Breakthrough Therapy Designation for IgAN, reflecting its potential to demonstrate substantial improvement over available therapies [7] - Vera Therapeutics is also developing MAU868, a monoclonal antibody designed to neutralize BK virus infection, particularly in kidney transplant settings [4] Company Background - Vera Therapeutics is a late clinical-stage biotechnology company focused on developing transformative treatments for serious immunological diseases [4] - The company retains global developmental and commercial rights to atacicept and MAU868 [4]
Vera Therapeutics Provides Business Update and Reports Second Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-08-08 12:00
Received FDA Breakthrough Therapy Designation for atacicept in IgA Nephropathy (IgAN) Presented data from Phase 2b ORIGIN study at ERA24 Congress showing atacicept stabilized kidney function through 72 weeks and led to rapid reductions in hematuria Topline 96-week data from Phase 2b ORIGIN study expected in Q4 2024 On track to complete enrollment in pivotal Phase 3 ORIGIN 3 trial for primary endpoint in Q3 2024; topline data expected in Q2 2025 BRISBANE, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Vera Therap ...
Vera Therapeutics Appoints Christy J. Oliger to Board of Directors
GlobeNewswire News Room· 2024-06-11 20:01
"We are delighted to welcome Christy to our Board during this important period in Vera's history. Her extensive experience and counsel will be a valuable resource for the executive team as we advance the development of atacicept for the treatment of IgAN and begin planning for atacicept's potential commercial launch," said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. Ms. Oliger currently serves on multiple public company boards, including Karyopharm Therapeutics, Replimune Group, and LAVA T ...