Arvinas LLC(ARVN)
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Arvinas to Report Second Quarter 2025 Financial Results on August 6, 2025
Globenewswire· 2025-07-30 20:05
Core Insights - Arvinas, Inc. is set to review its financial results for Q2 2025 and provide a corporate update on August 6, 2025 [1] - The company specializes in targeted protein degradation therapies through its PROTAC platform, aiming to treat various life-threatening diseases [3] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing drugs that utilize the body's natural protein disposal system to eliminate disease-causing proteins [3] - The company is advancing multiple investigational drugs, including vepdegestrant for ER+/HER2- breast cancer, ARV-393 for non-Hodgkin Lymphoma, ARV-102 for neurodegenerative disorders, and ARV-806 for KRAS G12D mutated cancers [3] Upcoming Events - A live webcast for the financial results and corporate update will be accessible on the Arvinas investor page, with a replay available post-event [2]
Arvinas Announces Retirement of Chief Executive Officer and Succession Plan
GlobeNewswire News Room· 2025-07-09 11:00
Core Points - John Houston, Ph.D., plans to retire as CEO of Arvinas after a successor is appointed, but will remain as Chairperson of the Board [1][2] - The Board of Directors is actively searching for a new CEO to ensure continued strong leadership [2] - Dr. Houston has been pivotal in advancing Arvinas' PROTAC programs, including the first positive pivotal Phase 3 trial [3][4] Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing targeted protein degradation therapies [5] - The company is advancing multiple investigational drugs, including vepdegestrant for ER+/HER2- breast cancer and ARV-393 for non-Hodgkin lymphoma [5]
Wall Street Analysts Believe Arvinas (ARVN) Could Rally 89.85%: Here's is How to Trade
ZACKS· 2025-06-16 14:56
Group 1 - Arvinas, Inc. (ARVN) shares have increased by 13.9% over the past four weeks, closing at $7.39, with a mean price target of $14.03 indicating a potential upside of 89.9% [1] - The mean estimate is based on 17 short-term price targets with a standard deviation of $4.54, where the lowest estimate is $8 (8.3% increase) and the highest is $24 (224.8% increase) [2] - Analysts show strong agreement in revising earnings estimates higher, which correlates with potential stock price movements [11][12] Group 2 - The Zacks Consensus Estimate for ARVN has increased by 5.5% due to two upward revisions in earnings estimates over the last 30 days [12] - ARVN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential upside [13] - While price targets are often viewed skeptically, the direction implied by the consensus price target suggests a positive outlook for ARVN [10][13]
Arvinas Presents Preclinical Data for PROTAC BCL6 Degrader, ARV-393, at the European Hematology Association 2025 Congress
Globenewswire· 2025-06-13 11:00
Core Insights - Arvinas, Inc. presented promising preclinical data for ARV-393, a PROTAC BCL6 degrader, showing significant single-agent activity in models of nodal T-follicular helper cell lymphoma and transformed follicular lymphoma, as well as enhanced antitumor activity in combination with small molecule inhibitors in aggressive diffuse large B-cell lymphoma models [1][2][3] Group 1: Preclinical Study Findings - ARV-393 demonstrated robust tumor growth inhibition (≥95%) in two patient-derived xenograft models of transformed follicular lymphoma [4] - In combination with five classes of small molecule inhibitors, ARV-393 showed increased tumor growth inhibition in cell line-derived xenograft models of high-grade B-cell lymphoma and aggressive diffuse large B-cell lymphoma compared to monotherapy [4] - RNA sequencing studies indicated that ARV-393 inhibits tumor cell cycle progression and promotes differentiation, contributing to its antitumor activity [4] Group 2: Clinical Development - A Phase 1 study of ARV-393 is currently enrolling adult patients with relapsed/refractory non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and nodal T-follicular helper cell lymphoma [2] - The company is exploring combination strategies, including chemotherapy-free approaches, to enhance treatment options for adult patients with lymphoma [2] Group 3: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing protein degradation therapies through its PROTAC platform, targeting various diseases including non-Hodgkin lymphoma [6] - The company is advancing multiple investigational drugs, including ARV-393 for BCL6, vepdegestrant for ER+/HER2- breast cancer, ARV-102 for neurodegenerative disorders, and ARV-806 for KRAS G12D mutated cancers [6]
绿谷医药阿尔茨海默症药物停产;全球首个PROTAC药物申报上市 | 医药早参
Mei Ri Jing Ji Xin Wen· 2025-06-08 23:59
Group 1 - Arvinas and Pfizer submitted a New Drug Application (NDA) for Vepdegestrant, the first PROTAC drug to seek approval, targeting advanced or metastatic breast cancer patients with ESR1 mutations [1] - The approval of Vepdegestrant could fill a significant treatment gap in the breast cancer market, attracting substantial investment and enhancing the overall industry valuation [1] Group 2 - Beijing Tide Pharmaceutical's TDI01 has been proposed for inclusion as a breakthrough therapy for chronic graft-versus-host disease (cGVHD), indicating its potential in a complex treatment area [2] - TDI01 is a novel ROCK2 inhibitor, and its breakthrough designation could significantly enhance the company's valuation and attract investor interest, bolstering China's innovative drug competitiveness [2] Group 3 - Anke Biotech anticipates significant sales growth for its trastuzumab product, Ansaiting, projecting over 100 million yuan in revenue for 2024 [3] - The positive market performance of Ansaiting enhances Anke Biotech's position in the oncology sector, potentially attracting more investors and supporting future research and market expansion [3] Group 4 - Haiwang Bio announced the termination of its control change and stock issuance, indicating ongoing discussions with state-owned entities for potential equity cooperation [4] - The proactive approach to resource integration and business collaboration may create new growth opportunities for Haiwang Bio, positively influencing market perceptions of its long-term value [4] Group 5 - Green Valley Pharmaceutical has ceased production of its Alzheimer's drug, Ganluo Sodium Capsules, following concerns over its efficacy and safety [6] - The shutdown reflects significant operational adjustments for the company, potentially leading to investor concerns about its future prospects and market confidence [6]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Arvinas, Inc. - ARVN
GlobeNewswire News Room· 2025-06-06 16:20
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Arvinas, Inc. and its officers or directors [1] Company Developments - On May 1, 2025, Arvinas announced the removal of plans for a Phase 3 first-line combination trial with atirmociclib and a Phase 3 second-line combination trial with a CDK4/6 inhibitor from its joint development plan with Pfizer [3] - The decision to remove these trials was based on a review of emerging information, external data results, the evolving treatment landscape in metastatic breast cancer, and long-term capital allocation [3] - Arvinas also announced a workforce reduction of approximately one-third to streamline operations and enable efficient progression of its portfolio, with completion planned for the second quarter of 2025 [3] - Following this news, Arvinas's stock price fell by $2.39 per share, or 24.84%, closing at $7.23 per share on May 1, 2025 [3]
Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer
Globenewswire· 2025-06-06 11:00
Core Viewpoint - Arvinas, Inc. has submitted a New Drug Application (NDA) to the FDA for vepdegestrant, a potential treatment for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer, based on positive results from the Phase 3 VERITAC-2 clinical trial [1][2] Group 1: Clinical Trial Details - The VERITAC-2 trial is a global, randomized Phase 3 study evaluating the efficacy and safety of vepdegestrant compared to fulvestrant in 624 patients across 25 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy [3][4] - Patients in the trial were randomized 1:1 to receive either vepdegestrant or fulvestrant, with 43% of patients having ESR1 mutations detected [4] - The primary endpoint of the trial was progression-free survival (PFS) in both the ESR1-mutation and intent-to-treat populations, with overall survival as a key secondary endpoint [4] Group 2: Drug Development and Collaboration - Vepdegestrant is an investigational PROTAC protein degrader designed to target and degrade the estrogen receptor, being developed as a potential monotherapy for advanced or metastatic ER+/HER2- breast cancer with ESR1 mutations [5][6] - Arvinas and Pfizer have a global collaboration for the co-development and co-commercialization of vepdegestrant, sharing worldwide development costs, commercialization expenses, and profits [6] Group 3: Regulatory Status and Future Outlook - The FDA has granted vepdegestrant Fast Track designation as a monotherapy for the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy [6] - The results from the VERITAC-2 study were presented at the 2025 ASCO Annual Meeting and published in the New England Journal of Medicine, highlighting the significance of the findings [2]
Arvinas (ARVN) 2025 Conference Transcript
2025-06-05 19:35
Summary of Arvinas (ARVN) Conference Call Company Overview - Arvinas is focused on protein degradation and was founded in 2013 by Craig Kruse at Yale University, being the first company in this space [1][2] - The company has achieved several milestones, including being the first to obtain INDs, enter phase one and phase two trials, and complete pivotal trials with positive data for ProTAC technology [2][3] Core Technology and Benefits - Protein degradation technology allows for the elimination of targeted proteins through the cell's natural degradation system, offering advantages over traditional inhibitors [3][4] - ProTACs are catalytic, allowing for multiple rounds of degradation, and are orally bioavailable with broad tissue distribution [4][5] - The technology shows promise in oncology by overcoming resistance mechanisms and targeting previously undruggable targets [5][6] Current Portfolio and Collaborations - The primary focus is on Vebdegastrant (ER degrader) in partnership with Pfizer, with pivotal trial data recently presented at ASCO [7][9] - Other programs include ARV393 (BCL6 degrader), ARV102 (LARC2 degrader), and ARV806 (KRAS G12D degrader), with several in various stages of clinical trials [8][12] - The company has a strong capital position with nearly $1 billion in cash, providing a runway into the second half of 2028 [12] Clinical Data and Future Plans - Vebdegastrant showed a median progression-free survival (PFS) of 5 months in the ESR1 mutant group, outperforming fulvestrant by 2.9 months [9][10] - The NDA submission for Vebdegastrant is imminent, with plans for a potential launch in 2026 [11][12] - Upcoming data releases include results from the SCD cohort and initial phase one data for ARV393 and ARV806 [11][12] Strategic Considerations and Market Position - The partnership with Pfizer is under review, with discussions on potential changes to the collaboration structure due to evolving market conditions [13][14] - There is a belief that Vebdegastrant has opportunities in both second-line and first-line settings, although Pfizer has expressed hesitance to pursue first-line development [15][16] - The market for second-line treatments is estimated to be significantly larger than current figures, with potential sales for Vebdegastrant projected in the range of $500 million to $700 million [24][68] Investor Insights and Future Catalysts - The company is focused on balancing the potential of Vebdegastrant with other promising assets in its pipeline, including LARC2 and KRAS G12D [48][64] - Key inflection points for upcoming clinical data are expected by the end of 2026, with interim data available along the way [75][79] - The company aims to maintain a strong cash position while exploring strategic partnerships or licensing opportunities for its assets [52][84] Conclusion - Arvinas is positioned as a leader in the protein degradation space with a robust pipeline and strategic partnerships, while navigating challenges in collaboration and market dynamics. The upcoming clinical data and potential NDA submissions are critical for the company's future growth and investor confidence.
Arvinas to Present Preclinical Data for PROTAC BCL6 Degrader, ARV-393, at the 2025 European Hematology Association (EHA) Annual Meeting
Globenewswire· 2025-06-05 12:28
Core Insights - Arvinas, Inc. is set to present new preclinical data for ARV-393, an investigational oral PROTAC BCL6 degrader, at the European Hematology Association meeting in June 2025 [1][2] - ARV-393 targets the B-cell lymphoma 6 protein (BCL6), which is a significant driver of B-cell lymphomas, and aims to address the challenges of traditional undruggable targets [3][4] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies that utilize targeted protein degradation to treat life-threatening diseases [4] - The company is advancing multiple investigational drugs, including ARV-393 for relapsed/refractory non-Hodgkin lymphoma, vepdegestrant for ER+/HER2- breast cancer, and ARV-102 for neurodegenerative disorders [4] Presentation Details - The presentation of ARV-393 will occur on June 13, 2025, during a session focused on lymphoma biology and translational research [2]
Arvinas (ARVN) Earnings Call Presentation
2025-06-02 14:09
VERITAC-2 Trial Results - Vepdegestrant demonstrated a 5-month median PFS in patients with tumors harboring ESR1 mutations, a 2.9-month improvement over fulvestrant[17] - In the ESR1 mutant population, the 6-month PFS was 45.2% with vepdegestrant compared to 22.7% with fulvestrant[33] - Vepdegestrant showed statistically significant improvements in CBR and ORR in the ESR1 mutant population[37] - In patients with ESR1m, CBR was 42.1% for Vepdegestrant vs 20.2% for Fulvestrant, ORR was 18.6% for Vepdegestrant vs 4.0% for Fulvestrant[40] - In the ITT population, median PFS by BICR was 3.7 months for Vepdegestrant and 3.6 months for Fulvestrant[35] Safety and Tolerability - The rate of treatment discontinuation due to TEAEs was 3% in the vepdegestrant group and 1% in the fulvestrant group[45] - Any grade TRAEs occurred in 57% of patients treated with vepdegestrant and 40% of patients treated with fulvestrant[45] Market and Regulatory - Approximately 20,000 patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer are treated each year in the U S in the 2L setting[17, 51, 52] - Arvinas and Pfizer plan to submit a New Drug Application to the U S Food and Drug Administration in the coming weeks[60]