Arvinas LLC(ARVN)

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Arvinas Reports First Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-01 11:00
Core Insights - Arvinas, Inc. reported positive topline results from the Phase 3 VERITAC-2 trial, supporting global regulatory filings for vepdegestrant, a PROTAC treatment for metastatic breast cancer [1][6][30] - The company announced a workforce reduction of approximately one-third to extend its cash runway into the second half of 2028 [5][11][30] - Revenue for Q1 2025 was $188.8 million, a significant increase from $25.3 million in Q1 2024, primarily due to the Vepdegestrant collaboration with Pfizer [21][39] Company Developments - Vepdegestrant is positioned as a competitive monotherapy for metastatic breast cancer in the second-line ESR1 mutant setting, with plans for regulatory submission [2][24] - The company has removed two Phase 3 combination trials from its development plan, focusing instead on maximizing patient benefit and shareholder value [2][11] - Arvinas presented first-in-human data for ARV-102, showing significant LRRK2 degradation, and plans to continue its clinical trials [5][10][27] Financial Performance - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $954.3 million, down from $1,039.4 million at the end of 2024 [15] - Research and development expenses for Q1 2025 were $90.8 million, an increase from $84.3 million in Q1 2024, driven by external expenses [16][18] - General and administrative expenses rose to $26.6 million in Q1 2025 from $24.3 million in Q1 2024, primarily due to increased professional fees [19][20] Upcoming Milestones - The company plans to present detailed results from the VERITAC-2 trial at the 2025 ASCO Annual Meeting and submit a new drug application to the FDA in the second half of 2025 [17][30] - Arvinas aims to initiate a first-in-human Phase 1 trial for ARV-806 in patients with solid tumors harboring KRAS G12D mutations in the second half of 2025 [13][31] - Continued recruitment for the Phase 1 clinical trial of ARV-102 in patients with non-Hodgkin lymphoma is expected, with initial data presentation planned for the second half of 2025 [10][31]
Arvinas to Report First Quarter 2025 Financial Results on Thursday, May 1, 2025
GlobeNewswire News Room· 2025-04-28 11:00
Company Overview - Arvinas, Inc. is a clinical-stage biotechnology company focused on developing a new class of drugs based on targeted protein degradation [3] - The company is headquartered in New Haven, Connecticut and aims to improve the lives of patients with debilitating and life-threatening diseases [3] Financial Results and Corporate Update - Management will review the first quarter 2025 financial results and provide a corporate update during a live webcast on May 1, 2025, at 8:00 a.m. ET [1] - The webcast will be accessible under "Events and Presentations" on the investor page of the Arvinas website, with a replay available afterward [2] Drug Development Pipeline - Arvinas is advancing multiple investigational drugs through clinical development programs, including: - Vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer [3] - ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma [3] - ARV-102, targeting LRRK2 for neurodegenerative disorders [3] Technology Platform - The company utilizes its PROTAC® (PROteolysis Targeting Chimera) protein degrader platform to develop therapies that selectively degrade and remove disease-causing proteins [3]
Arvinas Shares New Preclinical Combination Data for the PROTAC BCL6 Degrader, ARV-393, at the 2025 American Association for Cancer Research Annual Meeting
Globenewswire· 2025-04-28 10:45
Core Insights - Arvinas, Inc. presented promising preclinical data for ARV-393, a PROTAC BCL6 degrader, showing strong synergistic antitumor activity in combination with standard-of-care treatments for aggressive B-cell lymphomas [1][2][4] Group 1: Study Findings - ARV-393 demonstrated complete tumor regressions in high-grade B-cell lymphoma and aggressive diffuse large B-cell lymphoma models when combined with standard-of-care chemotherapy and biologics [1][4] - The combination of ARV-393 with R-CHOP chemotherapy resulted in significantly greater tumor growth inhibition compared to R-CHOP or ARV-393 alone, with complete regressions observed in all treated mice [4] - Combinations of ARV-393 with investigational small molecule inhibitors targeting oncogenic drivers like BTK, BCL2, and EZH2 also led to superior tumor growth inhibition and regressions in all treated mice [4] Group 2: Clinical Development - A Phase 1 clinical trial of ARV-393 is currently enrolling patients with relapsed/refractory non-Hodgkin lymphoma, including DLBCL [2][5] - The preclinical data support the potential for broad combinability of ARV-393, providing a rationale for further exploration of combination strategies in lymphoma treatment [2][5] Group 3: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies based on targeted protein degradation, with a pipeline that includes ARV-393 for non-Hodgkin lymphoma and other investigational drugs for various conditions [6]
Arvinas Announces Results from the VERITAC-2 Trial Selected as Late-Breaking Oral Presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
Globenewswire· 2025-04-23 14:44
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]
Arvinas to Present Preclinical Data for PROTAC BCL6 Degrader, ARV-393, at 2025 American Association for Cancer Research® (AACR) Annual Meeting
Newsfilter· 2025-04-21 11:00
Core Insights - Arvinas, Inc. announced new preclinical combination data for ARV-393, which will be presented at the AACR Annual meeting, highlighting its potential to be combined with standard lymphoma treatments [1][2] Group 1: Product Information - ARV-393 is an investigational PROteolysis TArgeting Chimera (PROTAC) designed to degrade B-cell lymphoma 6 protein (BCL6), a key driver of B-cell lymphomas [2][4] - The degradation of BCL6 through PROTAC technology aims to address the traditionally undruggable nature of this protein, which plays a significant role in B cell tolerance and proliferation [4] Group 2: Presentation Details - The presentation of ARV-393 will take place on April 28, 2025, at the AACR Annual meeting, with the poster titled "ARV-393, a PROteolysis TArgeting Chimera (PROTAC) BCL6 Degrader, Combined With Biologics or Small-Molecule Inhibitors Induces Tumor Regressions in Diffuse Large B-Cell Lymphoma Models" [3] - The session will focus on experimental and molecular therapeutics, specifically under the title "Degraders and Glues 2" [3] Group 3: Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies that utilize the body's natural protein disposal system to selectively degrade disease-causing proteins [5] - The company is advancing multiple investigational drugs, including vepdegestrant for ER+/HER2- breast cancer, ARV-393 for non-Hodgkin lymphoma, and ARV-102 for neurodegenerative disorders [5]
After Plunging -25.42% in 4 Weeks, Here's Why the Trend Might Reverse for Arvinas (ARVN)
ZACKS· 2025-04-09 14:35
Core Viewpoint - Arvinas, Inc. (ARVN) is experiencing significant selling pressure, with a 25.4% decline over the past four weeks, but is now positioned for a potential trend reversal due to being in oversold territory and positive earnings expectations from Wall Street analysts [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is used to determine if a stock is oversold, with a reading below 30 typically indicating this condition [2]. - ARVN's current RSI reading is 20.28, suggesting that the heavy selling pressure may be exhausting itself and a trend reversal could occur soon [5]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts that ARVN will report better earnings than previously predicted, leading to a 0.7% increase in the consensus EPS estimate over the last 30 days [7]. - ARVN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a potential turnaround [8].
Arvinas Potential Parkinson's Treatment Shows Positive Data In Human Study
Benzinga· 2025-04-04 19:38
Core Insights - Arvinas, Inc. has presented first-in-human data for its experimental Parkinson's disease treatment, ARV-102, at the 2025 International Conference on Alzheimer's and Parkinson's Diseases [1] Group 1: Clinical Trial Details - The Phase 1 trial included single ascending dose (SAD) cohorts ranging from 10 mg to 200 mg and multiple ascending dose (MAD) cohorts from 10 mg to 80 mg in healthy volunteers [2] - ARV-102, a PROteolysis TArgeting Chimera (PROTAC) LRRK2 degrader, showed a substantial reduction of LRRK2 in cerebrospinal fluid (CSF) [2] - A single oral dose of at least 60 mg ARV-102 resulted in over 50% reduction of LRRK2 protein in CSF and more than 90% reduction in peripheral blood mononuclear cells [3] Group 2: Safety and Tolerability - The trial demonstrated an encouraging safety and tolerability profile, with the most common treatment-related issues being headaches (17.1%) and fatigue (8.6%), although fatigue was more prevalent among placebo recipients (25%) [4] - Early data suggest that ARV-102 was well tolerated among the 47 volunteers across all SAD dose levels [4] Group 3: Future Plans and Market Reaction - In Q4 2024, Arvinas initiated dosing in the SAD cohort of the Phase 1 clinical trial with ARV-102 in patients with Parkinson's disease [5] - The company anticipates completing enrollment and presenting initial data from the ongoing SAD cohort in patients with Parkinson's disease, as well as initiating the MAD cohort in 2025 [5] - Following the announcement, ARVN stock experienced a decline of 4.93%, trading at $6.56 [5]
Arvinas Presents First-in-Human Data for Investigational Oral PROTAC ARV-102 Demonstrating Blood-Brain Barrier Penetration, and Central and Peripheral LRRK2 Degradation
Newsfilter· 2025-04-04 11:00
Core Insights - Arvinas, Inc. presented data from the first-in-human clinical trial of ARV-102, demonstrating its potential in reducing LRRK2 protein associated with neurodegenerative diseases like Parkinson's disease and progressive supranuclear palsy [1][3][7] Group 1: Clinical Trial Findings - ARV-102 was well tolerated and showed substantial LRRK2 reduction in both central and peripheral systems, indicating effective protein degradation [1][5] - The Phase 1 trial included a single ascending dose (SAD) cohort with doses from 10 mg to 200 mg and a multiple ascending dose (MAD) cohort with doses from 10 mg to 80 mg [2][3] - At doses of 60 mg or higher, ARV-102 achieved over 50% LRRK2 reduction in cerebrospinal fluid (CSF) and over 90% reduction in peripheral blood mononuclear cells (PBMCs) [5][9] Group 2: Safety and Tolerability - No serious adverse events were reported, and the drug was generally safe and well tolerated among healthy volunteers [4][5] - Common treatment-related adverse events included headache (17.1%) and fatigue (8.6%), with procedural pain from lumbar puncture reported in 28.6% of treated individuals [9] Group 3: Pharmacokinetics and Pharmacodynamics - ARV-102 demonstrated dose-dependent increases in exposure in both plasma and CSF, with a median terminal plasma half-life of 73 hours [9] - The drug's pharmacodynamic effects included significant reductions in phospho-Rab10T73 and bis(monoacylglycerol)phosphate (BMP) in urine, indicating engagement with downstream LRRK2 pathways [5][9] Group 4: Future Directions - Arvinas plans to continue the clinical program for ARV-102, with ongoing trials in patients with Parkinson's disease and expectations to present initial data in 2025 [7][10]
Arvinas Announces Oral Presentation at 2025 International Conference on Alzheimer's & Parkinson's Diseases
Newsfilter· 2025-03-27 11:00
Core Insights - Arvinas, Inc. is set to present data from its first-in-human study of ARV-102, a drug targeting LRRK2, at the International Conference on Alzheimer's and Parkinson's Diseases in April 2025 [1][3] - ARV-102 is designed as a PROTAC to degrade LRRK2, which is linked to Parkinson's disease and progressive supranuclear palsy [2][4] - The presentation will focus on the safety, pharmacokinetics, and pharmacodynamics of ARV-102 in healthy males [3] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies for serious diseases using its PROTAC platform [5] - The company is advancing multiple investigational drugs, including vepdegestrant for breast cancer, ARV-393 for non-Hodgkin lymphoma, and ARV-102 for neurodegenerative disorders [5] - Arvinas is headquartered in New Haven, Connecticut, and aims to improve patient outcomes through innovative protein degradation therapies [5]
Arvinas Announces Oral Presentation at 2025 International Conference on Alzheimer's & Parkinson's Diseases
GlobeNewswire News Room· 2025-03-27 11:00
NEW HAVEN, Conn., March 27, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical- stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, today announced that data from the first-in-human study evaluating single-ascending and multiple-ascending doses in healthy volunteers of ARV-102 will be presented at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD™), April 1-5, 2025 in Vienna, Austria. ARV-102 is Arvinas' investig ...