NEW HAVEN, Conn., Nov. 26, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that Noah Berkowitz, M.D., Ph.D., Chief Medical Officer, and Andrew Saik, Chief Financial Officer, will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Thursday, December 4 at 11:00 a.m. ET in New York. A live audio webcast of the presentation will be available her ...

Financial Data and Key Metrics Changes - As of the end of Q3 2025, the company had approximately $787.6 million in cash, cash equivalents, and marketable securities, down from $1.04 billion as of December 31, 2024 [31] - Revenue for Q3 2025 totaled $41.9 million, a decrease of $60.5 million compared to $102.4 million for Q3 2024, primarily due to the Novartis License agreement [31][32] - General and Administrative expenses were $21 million in Q3 2025, down from $75.8 million in the same period of 2024, mainly due to lease termination and reduced personnel costs [32] - Research and Development expenses were $64.7 million in Q3 2025, compared to $86.9 million in Q3 2024, driven by decreases in various programs [33] Business Line Data and Key Metrics Changes - The company reported significant progress in its clinical pipeline, including updates on ARV-102, ARV-393, and ARV-806, with multiple ongoing and planned clinical trials [12][14][27] - ARV-102 showed promising results in both healthy volunteers and Parkinson's disease patients, with significant reductions in LRRK2 protein levels [19][20][21] - ARV-393 demonstrated early responses in both B and T cell lymphomas, with ongoing dose escalation trials [25][26] Market Data and Key Metrics Changes - The company is focused on addressing significant unmet needs in oncology and neurology, with a deep pipeline of assets [13][14] - The FDA has issued a PDUFA action date of June 5, 2026, for the new drug application of vepdegestrant, with plans to have a commercialization partner in place before this date [15] Company Strategy and Development Direction - The company aims to deliver innovative and differentiated assets in areas of high unmet need, with a focus on progressing its early pipeline [37] - The strategic partnership with Pfizer for the commercialization of vepdegestrant is expected to enhance the company's market position [15] - The company is committed to maintaining a quarterly run rate spend below $75 million to manage expenses effectively [34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for ARV-102 and its ability to address neurodegenerative diseases, with plans for a phase 1b trial in PSP [12][37] - The company anticipates a data-rich period with multiple readouts from early-stage clinical programs, reinforcing its belief in the promise of its pipeline [13][14] - Management highlighted the importance of cost reduction programs and strategic flexibility to navigate the evolving market landscape [34] Other Important Information - The company has authorized the repurchase of up to $100 million of its outstanding common stock, reflecting confidence in its long-term strategy [34] - The company expects to maintain its cash runway into the second half of 2028, allowing for continued investment in high-value assets [36] Q&A Session Summary Question: Updates on the BCL6 degrader program - Management expressed excitement about the BCL6 program and its differentiation from competitors, highlighting ongoing studies and expected data at the upcoming ASH meeting [45][48] Question: Signals to look for in the Parkinson's disease MAD phase one - Management indicated that the ongoing phase one study aims to generate biomarker-related data, with expectations for clinical efficacy data to follow [54][56] Question: Plans for ARV806 in KRAS amplified populations - The company is studying ARV806 in resistance settings and has seen promising early data in models of KRAS amplification [61][63] Question: Dosing cohorts for ARV393 - Management confirmed that they are not yet in the predicted efficacious range for ARV393 but are seeing significant responses at lower dose levels [129][139] Question: Evaluating combination strategies for ARV806 - The company has preclinically evaluated combinations with anti-EGFR inhibitors and believes this selective approach will provide advantages [89][91]

Core Insights - Arvinas, Inc. is set to review its third-quarter 2025 financial results and provide a corporate update on November 5, 2025 [1] - The company specializes in targeted protein degradation therapies through its PROTAC platform, aiming to treat various debilitating diseases [3] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing therapies for life-threatening diseases [3] - The company utilizes its PROTAC (PROteolysis TArgeting Chimera) platform to create drugs that selectively degrade disease-causing proteins [3] - Current investigational drugs include ARV-102 for neurodegenerative disorders, ARV-393 for non-Hodgkin Lymphoma, ARV-806 for mutated cancers, and vepdegestrant for ER+/HER2- breast cancer [3]

Core Insights - Arvinas, Inc. announced preclinical data for ARV-806, a PROTAC KRAS G12D degrader, demonstrating significant tumor growth inhibition in models of pancreatic, colorectal, and lung cancer, highlighting its best-in-class potential for KRAS G12D mutated cancers [1][2][5] Group 1: Drug Development and Efficacy - ARV-806 showed robust and durable KRAS G12D degradation, leading to significant tumor growth inhibition in various cancer models [1] - The drug targets both ON and OFF forms of KRAS G12D, which is the most common mutation of the KRAS protein, addressing high unmet needs in solid tumors [1][5] - In vitro studies indicated that ARV-806 degraded KRAS G12D with picomolar potency across multiple cancer cell lines without affecting wild-type and other mutant RAS isoforms [6] - Following a single intravenous dose, ARV-806 achieved over 90% degradation of KRAS G12D for seven days, with sustained effects on c-MYC suppression and BIM induction for at least five days [6] Group 2: Clinical Trials and Future Potential - Arvinas is currently evaluating ARV-806 in a Phase 1 clinical trial for patients with KRAS G12D–mutated advanced solid tumors [3] - The data suggest that ARV-806's sustained pharmacodynamic activity supports intermittent clinical dosing, indicating a potential for effective treatment regimens [3][8] - The drug demonstrated over 25-fold greater potency in reducing cancer cell proliferation and over 40-fold higher potency in degrading KRAS G12D protein compared to other clinical-stage G12D degraders [6] 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 cancers with KRAS mutations [7] - The company is advancing multiple investigational drugs, including ARV-806 for KRAS G12D, vepdegestrant for ER+/HER2- breast cancer, and ARV-393 for non-Hodgkin lymphoma [7]

Core Insights - Vepdegestrant has shown statistically significant improvements in patient-reported outcomes (PROs) compared to fulvestrant, particularly in quality of life, pain, and daily functioning for patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer [1][2][3] Clinical Trial Findings - The Phase 3 VERITAC-2 clinical trial demonstrated that vepdegestrant delayed deterioration in overall health status, pain severity, and various functioning domains compared to fulvestrant [2][3] - The trial enrolled 624 patients, with 270 having ESR1 mutations, and the primary endpoint was progression-free survival (PFS) [7][8] - Vepdegestrant was administered orally once daily, while fulvestrant was given intramuscularly [8] Company Collaboration and Development - Arvinas is collaborating with Pfizer for the co-development and commercialization of vepdegestrant, sharing development costs and profits [10] - The FDA has accepted the New Drug Application (NDA) for vepdegestrant, granting it Fast Track designation, indicating a significant unmet need in the target patient population [11] Additional Clinical Insights - Results from the TACTIVE-N Phase 2 clinical trial indicated that neoadjuvant vepdegestrant showed biological and clinical activity in postmenopausal women with localized ER+/HER2- breast cancer [5] - The data from the VERITAC-2 trial support vepdegestrant's potential as a best-in-class therapy for the specified patient group [4]

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 Insights - Arvinas, Inc. is presenting clinical data for ARV-102, a PROTAC LRRK2 degrader, at the 2025 International Congress of Parkinson's Disease and Movement Disorders [1][2] - ARV-102 is designed to target LRRK2, which is implicated in neurological diseases, particularly Parkinson's disease [3] Company Overview - Arvinas is a clinical-stage biotechnology company focused on developing protein degradation therapies to treat debilitating diseases [4] - The company is advancing multiple investigational drugs, including ARV-102 for neurodegenerative disorders and others targeting various cancers [4] Presentation Details - The presentations include a first-in-human study assessing the safety and pharmacokinetics of ARV-102 and a late breaker session on its clinical trials [2][6] - Specific presentation times and poster numbers are provided for the sessions at the congress [6]

Core Viewpoint - Pfizer has not abandoned vepdegestrant but has deprioritized it, seeking new partners for the project with Arvinas, reflecting the challenges in the innovative drug industry [1][2][4] Group 1: Clinical Trial Results - The VERITAC-2 trial results showed that vepdegestrant achieved one of its dual primary endpoints in ESR1 mutant patients but failed to demonstrate significant improvement in progression-free survival (PFS) in the intent-to-treat population [2][3] - The trial's outcome indicates that vepdegestrant could not meet its core objective of covering the entire patient population, missing out on a significant market opportunity [2][3] Group 2: Market Position and Competition - Vepdegestrant is likely to struggle in a highly competitive market, as it has not differentiated itself from other second-generation SERDs, with Menarini's elacestrant showing superior clinical benefits [3][4] - The decision to seek new partners suggests that both Pfizer and Arvinas are acknowledging the limited competitive edge of vepdegestrant in the current landscape [4][5] Group 3: Company Performance and Market Sentiment - Arvinas has seen its market value plummet from a peak of $8 billion to approximately $552 million, illustrating the volatility and risks associated with innovative drug development [6] - The initial excitement surrounding vepdegestrant's early clinical data has not translated into sustained market success, highlighting the unpredictability of clinical trials [6][7] Group 4: Industry Insights - The situation with vepdegestrant serves as a cautionary tale for the innovative drug sector, emphasizing the gap between early expectations and later clinical realities [1][6] - The broader innovative drug industry is characterized by a pattern of high expectations followed by significant challenges, necessitating a cautious yet optimistic approach [7]

Market Overview - US stock market indices, including the Dow Jones, Nasdaq, S&P 500, and Russell 2000, reached both intraday and closing historical highs on Thursday, driven by signals from the Federal Reserve indicating an upcoming interest rate cut cycle [1][3] - The Dow Jones increased by 124.10 points (0.27%) to 46,142.42, the Nasdaq rose by 209.40 points (0.94%) to 22,470.73, the S&P 500 gained 31.61 points (0.48%) to 6,631.96, and the Russell 2000 surged by 59.317 points (2.46%) to 2,466.662 [3] Economic Indicators - The Federal Reserve is expected to lower the benchmark interest rate by 25 basis points, with two additional cuts anticipated this year, boosting investor sentiment regarding economic growth [3][4] - Initial jobless claims in the US decreased by 33,000 to 231,000, marking the largest drop in nearly four years, aligning with low layoff levels in the economy [5] Company Highlights - Intel's stock surged approximately 26% following Nvidia's announcement of a $5 billion investment to co-develop data center and personal computer chips, which also led to a more than 3% increase in Nvidia's stock [3][6] - Palantir secured a $750 million contract to expand its presence in the UK market [6] - Tesla received an order for 10,000 units of its Optimus 3+ humanoid robots [6] - TSMC's stock rose amid reports that Apple has secured over half of the 2nm production capacity for next year [6] Sector Performance - Small-cap companies, represented by the Russell 2000, are expected to benefit more from low interest rates due to their reliance on external funding for operations and growth [3] - Semiconductor stocks experienced a rally, driven by Intel's performance and Nvidia's investment announcement [6] - Quantum computing stocks saw a broad increase, continuing the upward trend from the previous day [6]

Market Movements - U.S. stock index futures are all up, with Dow futures rising by 0.65%, S&P 500 futures up by 0.81%, and Nasdaq futures increasing by 1.09% [1] - European indices also show positive movement, with Germany's DAX up by 1.35%, UK's FTSE 100 up by 0.29%, France's CAC40 up by 1.23%, and the Euro Stoxx 50 up by 1.55% [1] - WTI crude oil is up by 0.34%, priced at $64.27 per barrel, while Brent crude oil is up by 0.28%, priced at $68.14 per barrel [1][2] Market News - Small-cap stocks are regaining focus as expectations for Federal Reserve rate cuts rise, with the Russell 2000 index rising by 2.1% to 2453.36 points, marking its first breach of the historical closing high since November 2021 [3] - Despite the Fed's rate cut, market volatility is expected to increase due to uncertainty about future rate cuts, with significant internal disagreements within the Fed regarding policy outlook for 2026 [4] Corporate News - 71% of U.S. CEOs express concerns that tariffs are damaging businesses, highlighting frustrations with the current business environment during a closed-door meeting at Yale [5] - Deutsche Bank raises its forecast for the average gold price in 2026 to $4000 per ounce, citing continued demand from central banks and the impact of Fed rate cuts [5] Individual Stocks - Novo Nordisk's stock jumps nearly 7% after its diabetes drug Ozempic shows superior cardiovascular protection compared to Eli Lilly's Trulicity, with a 23% lower risk of heart attack, stroke, or death for Ozempic users [6] - FedEx's upcoming earnings report is seen as a critical indicator for the sustainability of the current bull market, amid concerns over the divergence between industrial and transportation indices [6] - Bullish reports a significant earnings increase, with Q2 EPS at $0.93, surpassing market expectations, and shares rise nearly 9% [7] - Palantir commits to investing £1.5 billion in the UK and secures a £750 million contract with the UK Ministry of Defence [7] - Roche acquires 89bio for up to $3.5 billion to expand into the weight loss drug market, with 89bio's key drug targeting metabolic diseases [8][9] - Arvinas partners with Pfizer to commercialize a breast cancer drug, with shares rising over 2% [9]