Core Insights - Arvinas, Inc. reported significant progress in its clinical pipeline, including positive Phase 1 trial data for ARV-102 in Parkinson's disease and promising preclinical results for ARV-806 and ARV-027 [1][3][6][11] - The company announced a collaboration with Pfizer for the commercialization and further development of vepdegestrant, an investigational drug for breast cancer [1][10][30] - Financial results for Q3 2025 showed a decrease in revenue and operating expenses, with cash reserves sufficient to fund operations into the second half of 2028 [14][15][21] Clinical Developments - ARV-102 demonstrated well-tolerated results in healthy volunteers and Parkinson's patients, with significant reductions in LRRK2 protein levels [6][24] - ARV-806 showed robust anti-tumor activity in preclinical models of KRAS G12D-mutant cancers, with a Phase 1 trial initiated [11][26] - ARV-027 exhibited effective degradation of polyQ-AR in muscle, supporting its potential as a disease-modifying therapy for spinal bulbar muscular atrophy [1][9][27] Financial Performance - Revenue for Q3 2025 was $41.9 million, down from $102.4 million in Q3 2024, primarily due to decreased revenue from previous collaborations [21] - Research and development expenses decreased to $64.7 million from $86.9 million year-over-year, reflecting reduced external costs [16] - The company reported a net loss of $35.1 million for Q3 2025, compared to a loss of $49.2 million in the same quarter of the previous year [39] Strategic Collaborations - The agreement with Pfizer aims to enhance the commercialization potential of vepdegestrant, with plans to select a third-party partner for further development [10][30] - The collaboration underscores the strategic focus on bringing innovative therapies to market, particularly in oncology and neurodegenerative diseases [1][23] Future Outlook - Arvinas plans to initiate multiple clinical trials in 2026, including a Phase 1b trial for ARV-102 in progressive supranuclear palsy and a trial for ARV-027 [1][12][29] - The company is positioned for a data-rich period with several upcoming readouts from its clinical programs, aiming to drive innovation in its PROTAC degrader portfolio [3][10]

Core Insights - Arvinas, Inc. announced the presentation of preclinical data for ARV-806, a PROTAC KRAS G12D degrader, at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics [1] - ARV-806 targets the KRAS G12D mutation, which is prevalent in various solid tumors, indicating a significant unmet medical need [2] - The company is advancing multiple investigational drugs, including ARV-806, through clinical development programs [3] Group 1: ARV-806 Presentation Details - Title of the presentation: Preclinical Activity of ARV-806, a PROTAC KRAS G12D Degrader [1] - Presentation type: Poster presentation, scheduled for October 24, 2025, from 12:30-4pm ET [1] - Poster number: B107, part of Poster Session B [1] Group 2: About ARV-806 - ARV-806 is designed to selectively target and degrade the KRAS G12D mutation, which is the most common mutation of the KRAS protein [2] - The drug is currently in a Phase 1 clinical trial for patients with advanced solid tumors harboring KRAS G12D mutations [2] Group 3: About Arvinas - Arvinas is a clinical-stage biotechnology company focused on developing therapies that utilize the body's natural protein disposal system [3] - The company is also developing other investigational drugs targeting various conditions, including breast cancer and neurodegenerative disorders [3] - Arvinas is headquartered in New Haven, Connecticut [3]

Core Insights - Arvinas, Inc. is set to present new patient-reported outcomes data for vepdegestrant at the ESMO Congress from October 17 to 21, 2025, highlighting its potential as a treatment for advanced or metastatic breast cancer with ESR1 mutations [1][2] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing protein degradation therapies to treat life-threatening diseases, utilizing its PROTAC platform [6][7] - The company is headquartered in New Haven, Connecticut, and is advancing multiple investigational drugs, including vepdegestrant for breast cancer and others targeting various cancers and neurodegenerative disorders [7] Product Development - Vepdegestrant is an investigational PROTAC estrogen receptor degrader being developed as a monotherapy for ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations [3][5] - The FDA has accepted the New Drug Application for vepdegestrant, granting it Fast Track designation, indicating its potential as a new treatment option for patients previously treated with endocrine-based therapy [5] Collaboration and Commercialization - In July 2021, Arvinas entered a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant, with plans announced in September 2025 to select a third party for out-licensing and commercialization [4]

Core Viewpoint - The FDA has accepted the New Drug Application (NDA) for vepdegestrant, a novel treatment for advanced or metastatic breast cancer, with a PDUFA action date set for June 5, 2026 [1][5]. Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing therapies for life-threatening diseases using its PROTAC protein degrader platform [8]. - The company is collaborating with Pfizer for the co-development and commercialization of vepdegestrant, sharing development costs and profits [4]. Product Details - Vepdegestrant is an investigational oral PROTAC estrogen receptor degrader aimed at treating ER+/HER2- advanced or metastatic breast cancer with ESR1 mutations [3][5]. - The drug has shown statistically significant improvement in median progression-free survival compared to fulvestrant in the Phase 3 VERITAC-2 clinical trial [1][2]. Clinical Trial Information - The VERITAC-2 trial enrolled 624 patients across 213 sites in 25 countries, with 270 patients having ESR1 mutations [6][7]. - The primary endpoint of the trial was progression-free survival, with overall survival as a key secondary endpoint [7]. Regulatory Status - Vepdegestrant has been granted Fast Track designation by the FDA, highlighting the unmet medical need in the target patient population [5].

Core Insights - Arvinas, Inc. has made significant clinical and regulatory advancements, including the submission of a New Drug Application (NDA) for vepdegestrant, marking a milestone as the first PROTAC degrader to enter clinical trials and achieve a positive Phase 3 trial outcome [3][5] - The company reported a decrease in revenue for Q2 2025, primarily due to the completion of previous collaboration agreements, while maintaining a strong cash position to fund operations into the second half of 2028 [20][14] Clinical Developments - The NDA for vepdegestrant was submitted to the FDA for treating ESR1m, ER+/HER2- advanced or metastatic breast cancer, with pivotal trial results showing a 2.9-month improvement in median progression-free survival compared to fulvestrant [5][3] - Arvinas presented data from the Phase 1 clinical trial of ARV-102, demonstrating over 50% LRRK2 reduction in cerebrospinal fluid and over 90% reduction in peripheral blood mononuclear cells [10][6] - The company initiated a Phase 1 clinical trial for ARV-806 targeting KRAS G12D mutations in solid tumors [8][3] Financial Performance - For Q2 2025, Arvinas reported revenue of $22.4 million, a decrease from $76.5 million in Q2 2024, attributed to reduced collaboration revenue from Novartis and other agreements [20][14] - Research and development expenses were $68.6 million for the quarter, down from $93.7 million in the same period last year, reflecting a decrease in external expenses and personnel costs [15][14] - The company ended Q2 2025 with cash, cash equivalents, and marketable securities totaling $861.2 million, down from $1,039.4 million at the end of 2024 [14][20] Corporate Updates - John Houston, CEO and President of Arvinas, announced plans to retire, with the Board of Directors beginning a search for a new CEO while he will remain as Chairperson [11] - The company is preparing for upcoming milestones, including presenting patient-reported outcomes data from the VERITAC-2 trial at the European Society for Medical Oncology Congress in October 2025 [16][9]

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]

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]

Core Insights - Arvinas, Inc. announced the presentation of pivotal data from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant against fulvestrant for ER+/HER2- advanced or metastatic breast cancer at the 2025 ASCO Annual Meeting [1][3] - Vepdegestrant is being co-developed with Pfizer and is designed as a potential first-in-class oral PROTAC estrogen receptor degrader [2][4] Group 1: Clinical Trial and Presentation Details - The VERITAC-2 trial results will be presented as a late-breaking oral presentation on May 31, 2025, by Dr. Erika P. Hamilton [3] - The session will focus on the comparison of vepdegestrant and fulvestrant in treating advanced breast cancer [3] Group 2: Product Information - Vepdegestrant is an investigational PROTAC protein degrader targeting the estrogen receptor for ER+/HER2- breast cancer [4] - It is being developed for use as both a monotherapy and in combination therapies across various treatment settings [4] Group 3: Collaboration and Regulatory Status - Arvinas and Pfizer entered a global collaboration for the co-development and commercialization of vepdegestrant, sharing development costs and profits [5] - The FDA has granted vepdegestrant Fast Track designation for treating adults with advanced or metastatic ER+/HER2- breast cancer previously treated with endocrine therapy [5] Group 4: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing protein degradation therapies to treat life-threatening diseases [6] - The company is advancing multiple investigational drugs, including vepdegestrant, ARV-393 for non-Hodgkin lymphoma, and ARV-102 for neurodegenerative disorders [6]