Arvinas LLC(ARVN)

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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Arvinas, Inc. - ARVN
GlobeNewswire News Room· 2025-06-06 16:20
NEW YORK, June 06, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Arvinas, Inc. (“Arvinas” or the “Company”) (NASDAQ: ARVN). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Arvinas and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] On May 1, 2025, Arv ...
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
– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine – – VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer – NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug ...
Arvinas (ARVN) 2025 Conference Transcript
2025-06-05 19:35
Arvinas (ARVN) 2025 Conference June 05, 2025 02:35 PM ET Speaker0 My name is Akash Chewari. I am a pharma and biotech analyst here and we have the Arvenous management team. John, I'm gonna hand it off to you for some I think you have some slides you want to present and then we'll get started with the q and Thank Speaker1 Thanks for being here. I thought I'd start just by setting the scene around Arvinus and giving you a little bit of background of where we are today. So forward looking statements. So Arvinu ...
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
June 2, 2025 NASDAQ ARVN LISTED © 2025 Arvinas. All rights reserved. PHASE 3 VERITAC-2 TRIAL RESULTS 1 Safe harbor and forward-looking statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding vepdegestrant's potential to be a best-in-class treatment in estrogen receptor ("ER")-1 ("ESR1") mutant ER positive ("ER+"), human epidermal growth factor r ...
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.
Arvinas and Pfizer's Vepdegestrant Significantly Improves Progression-Free Survival for Patients with ESR1-Mutant, ER+/HER2- Advanced Breast Cancer
GlobeNewswire· 2025-05-31 12:00
Core Insights - The Phase 3 VERITAC-2 clinical trial results indicate that vepdegestrant monotherapy shows a statistically significant improvement in progression-free survival (PFS) for patients with ESR1 mutations compared to fulvestrant [2][4][6] - Vepdegestrant is positioned as a potential best-in-class treatment option for patients with ER+/HER2- advanced or metastatic breast cancer, particularly in the second-line setting [4][7][12] Group 1: Clinical Trial Results - Vepdegestrant reduced the risk of disease progression or death by 43% in patients with ESR1 mutations, with a median PFS of 5.0 months compared to 2.1 months for fulvestrant [2][3] - In the intent-to-treat population, the median PFS was 3.7 months for vepdegestrant versus 3.6 months for fulvestrant, which did not reach statistical significance [2][4] - The clinical benefit rate (CBR) for vepdegestrant was 42.1% compared to 20.2% for fulvestrant, and the objective response rate (ORR) was 18.6% versus 4.0% respectively [4][6] Group 2: Safety and Tolerability - Vepdegestrant was generally well tolerated, with low rates of gastrointestinal adverse events such as nausea (13.5%), vomiting (6.4%), and diarrhea (6.4%) [3][5] - The incidence of grade 4 treatment-emergent adverse events (TEAEs) was 1.6% in the vepdegestrant arm compared to 2.9% in the fulvestrant arm [3][5] - TEAEs leading to treatment discontinuation occurred in 2.9% of patients taking vepdegestrant versus 0.7% for fulvestrant [3][5] Group 3: Market and Development Potential - Approximately 2.3 million new breast cancer diagnoses were reported globally in 2022, with ER+/HER2- breast cancer accounting for about 70% of cases [6][12] - The companies plan to submit a New Drug Application (NDA) for vepdegestrant to the FDA in the second half of 2025 [7][12] - Vepdegestrant is the first PROTAC evaluated in a Phase 3 clinical trial, indicating a novel approach in treating breast cancer [5][7]
Does Arvinas (ARVN) Have the Potential to Rally 94.93% as Wall Street Analysts Expect?
ZACKS· 2025-05-30 14:55
Core Viewpoint - Arvinas, Inc. (ARVN) shows significant upside potential with a mean price target of $14.62, indicating a 94.9% increase from the current price of $7.50 [1] Price Targets and Estimates - The mean estimate consists of 17 short-term price targets with a standard deviation of $5.19, suggesting variability in analyst predictions [2] - The lowest estimate of $8 indicates a 6.7% increase, while the highest estimate suggests a 233.3% surge to $25 [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement [9] Analyst Sentiment and Earnings Estimates - Analysts have shown increasing optimism about ARVN's earnings prospects, as evidenced by a positive trend in earnings estimate revisions [11] - The Zacks Consensus Estimate for the current year has risen by 56.9% over the past month, with 11 estimates increasing and one decreasing [12] - ARVN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13]
Arvinas to Present at Jefferies Global Healthcare Conference
GlobeNewswire News Room· 2025-05-30 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 is listed on Nasdaq under the ticker ARVN [3] Drug Development - Arvinas is pioneering the PROTAC (PROteolysis Targeting Chimera) protein degrader platform, which aims to selectively and efficiently degrade disease-causing proteins [3] - The company is advancing multiple investigational drugs through clinical development, 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] Upcoming Events - Management will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5 at 2:35 p.m. ET in New York City [1] - A live audio webcast of the presentation will be available on the company's website [2]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Arvinas, Inc. - ARVN
Prnewswire· 2025-05-06 18:04
Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Arvinas, Inc. and its officers or directors [1] Group 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 second-line combination trial with a CDK4/6 inhibitor from its joint development plan with Pfizer [2] - 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 [2] - 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 [2] - 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 [2]