Arvinas LLC(ARVN)

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Arvinas Announces Retirement of Chief Executive Officer and Succession Plan
GlobeNewswire News Room· 2025-07-09 11:00
– John Houston, Ph.D., Chairperson, CEO and President at Arvinas, Announces Plans to Retire as CEO Upon Appointment of Successor – – Dr. Houston to Remain Chairperson of Arvinas Board of Directors – – Arvinas Board of Directors to Lead Search for CEO Replacement – NEW HAVEN, Conn., July 09, 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 John Houston, Ph.D., Chair ...
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
丨2025年6月9日星期一丨 6月8日,安科生物发布的投资者关系活动记录表显示,公司曲妥珠单抗(商品名:安赛汀)处于市场快 速导入阶段,2024年度销售收入超过1亿元。该产品上市以来,销售总体呈现上升趋势,2025年1至5 月"安赛汀"的发货同比持续保持增长,预计2025年"安赛汀"会有较大幅度的同比增长。资料显示,"安 赛汀"是安科生物在抗肿瘤靶向药物领域布局的首款产品。 点评:安科生物的表态背后,是曲妥珠单抗(商品名:安赛汀)市场表现释放出的积极信号。作为公司 抗肿瘤靶向药物领域的首款产品,安赛汀的成功不仅为公司带来新的利润增长点,还提升了其在肿瘤治 疗领域的市场地位和品牌影响力,有望吸引更多投资者关注,推动公司整体估值提升,为后续研发和市 场拓展提供有力支撑。 NO.4 海王生物发布终止控制权变更公告 6月6日晚,海王生物发布了关于终止控制权变更及向特定对象发行股票事项公告。广新集团及丝纺集团 终止认购海王生物本次发行的股份。海王生物表示,上述事项终止后,公司仍会与有意向的国资主体针 对股权合作事宜展开积极洽谈,探讨未来通过优势资源整合、深化业务协同等方式,拓展新的发展空 间,为公司创造新机遇。 NO. ...
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]
Arvinas (ARVN) Update / Briefing Transcript
2025-06-02 13:00
Summary of Arvinas ASCO Data Conference Call Company and Industry Overview - **Company**: Arvinas - **Industry**: Biotechnology, specifically focused on cancer treatment, particularly for ER positive HER2 negative breast cancer Key Points and Arguments 1. **Phase III VERITAGE II Study Results**: The conference discussed the results of the Phase III VERITAGE II study of beftegastrant (Vepdeg) as a monotherapy for ER positive HER2 negative breast cancer, highlighting its potential as a best-in-class second-line therapy for ESR1 mutant breast cancer [2][4][5] 2. **Mechanism of Action**: Vepdeg works by directly inducing degradation of the estrogen receptor via the proteasome, which differentiates it from other ER-targeting therapies [4][5] 3. **Unmet Medical Need**: There is a significant unmet need for effective treatments in the second-line setting for patients with ESR1 mutant metastatic breast cancer, with approximately 20,000 new patients diagnosed each year in the U.S. [6][7][19] 4. **Efficacy Data**: In the VERITAGE II trial, Vepdeg achieved a median progression-free survival (PFS) of 5.0 months compared to 2.1 months for fulvestrant, representing a statistically significant improvement of 2.9 months [12][22] 5. **Comparison with Other Treatments**: Vepdeg demonstrated a better PFS compared to other recent SERDs, such as elacestrant and molesterine, which showed improvements of 1.9 months and 1.7 months, respectively, over fulvestrant [7][8] 6. **Safety Profile**: Vepdeg was generally well tolerated, with low rates of treatment-emergent adverse events, particularly gastrointestinal issues, which are common with oral SERDs [17][19] 7. **Regulatory Plans**: Arvinas is on track to submit a new drug application (NDA) to the FDA in the coming weeks, indicating confidence in the product's potential [20][24] Additional Important Content 1. **Patient Population**: The trial included a representative real-world patient population, with all patients having received prior CDK4/6 inhibitors and endocrine therapy [12][22] 2. **Market Research Insights**: Clinicians remain underwhelmed by current monotherapy options, indicating a strong market opportunity for Vepdeg [19] 3. **Future Development**: Discussions with Pfizer regarding the commercialization strategy are ongoing, especially in light of the recent trial results and the potential for Vepdeg to be a leading treatment option [40][45] 4. **QT Prolongation Concerns**: The study noted a mild QT prolongation effect of 11.1 milliseconds, which was not considered a significant concern by investigators [70][71] 5. **Patient Reported Outcomes**: Future presentations will include patient-reported outcome data, which showed statistically significant improvements in quality of life and pain interference [20] This summary encapsulates the critical insights from the Arvinas ASCO Data Conference Call, focusing on the company's advancements in cancer treatment and the promising data surrounding Vepdeg.