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
Written by Emily J. Thompson, Senior Investment Analyst
Source: Newsfilter
New Drug Application Submission: Arvinas, in partnership with Pfizer, has submitted a New Drug Application (NDA) to the FDA for vepdegestrant, aimed at treating patients with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer, based on positive results from the Phase 3 VERITAC-2 clinical trial.
Clinical Trial Highlights: The VERITAC-2 trial involved 624 patients and compared vepdegestrant to fulvestrant, focusing on progression-free survival as the primary endpoint, with results recently presented at the ASCO 2025 Annual Meeting and published in The New England Journal of Medicine.
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Analyst Views on ARVN
Wall Street analysts forecast ARVN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ARVN is 14.25 USD with a low forecast of 6.00 USD and a high forecast of 18.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
10 Analyst Rating
6 Buy
3 Hold
1 Sell
Moderate Buy
Current: 13.380
Low
6.00
Averages
14.25
High
18.00
Current: 13.380
Low
6.00
Averages
14.25
High
18.00
About ARVN
Arvinas, Inc. is a clinical-stage biotechnology company. The Company, through its PROteolysis Targeting Chimera (PROTAC) protein degrader platform, is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. It is progressing multiple investigational drugs through clinical development programs, including vepdegestrant, ARV-393 and ARV-102. Vepdegestrant is an investigational orally bioavailable PROTAC protein degrader designed to target and degrade the ER for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. It is co-developing vepdegestrant with Pfizer. ARV-393 is an investigational, orally bioavailable PROTAC designed to degrade BCL6, a transcriptional repressor and a key regulator of normal B-cell maturation and differentiation processes. ARV-102 is in development to treat neurodegenerative diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Arvinas Initiates ARV-393 and Glofitamab Combination Trial for DLBCL Expected in 2026
- Clinical Trial Launch: Arvinas plans to initiate a combination clinical trial of ARV-393 and glofitamab in 2026, aiming to provide a chemotherapy-free treatment option for patients with diffuse large B-cell lymphoma, addressing a significant unmet medical need.
- Significant Efficacy: In a high-grade B-cell lymphoma model, the combination of ARV-393 and glofitamab achieved an 81% tumor growth inhibition rate, demonstrating substantial synergistic anti-tumor effects that could offer a more effective treatment option for patients.
- Mechanistic Research Support: RNA sequencing analysis revealed that ARV-393 upregulates CD20 expression and promotes interferon signaling pathways, indicating a strong mechanistic rationale for its combination with glofitamab, providing theoretical support for future clinical applications.
- Market Potential: As demand for chemotherapy-free treatment options increases, this research by Arvinas not only aims to improve patient quality of life but also positions the company to capture market share in the competitive biopharmaceutical landscape.
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Arvinas Initiates ARV-393 and Glofitamab Combination Trial for DLBCL, Expected in 2026
- Trial Initiation: Arvinas plans to initiate a combination clinical trial of ARV-393 and glofitamab in 2026, aiming to provide a chemotherapy-free treatment option for patients with diffuse large B-cell lymphoma, addressing a significant unmet medical need.
- Preclinical Data: In a high-grade B-cell lymphoma model, the combination of ARV-393 and glofitamab achieved an 81% tumor growth inhibition rate, demonstrating significant synergistic anti-tumor effects and indicating the clinical potential of this combination.
- Dose Optimization: At a higher dose of 6 mg/kg for ARV-393, the combination therapy showed increased tumor regression rates, with complete regression observed in 10 out of 10 mice, highlighting the efficacy and safety of this treatment approach.
- Mechanistic Insights: RNA sequencing revealed that ARV-393 upregulates CD20 expression and enhances interferon signaling pathways, which may provide a mechanistic basis for its synergistic effects with glofitamab, further supporting its clinical rationale.
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