Bullish indicating open at $55-$60, IPO prices at $37
NEW HAVEN, Conn. - Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotech company with a market capitalization of $505 million and impressive revenue growth of nearly 500% over the last twelve months, in collaboration with Pfizer Inc. (NYSE:PFE), announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug vepdegestrant. This application is for the treatment of patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer.
The NDA submission follows promising results from the Phase 3 VERITAC-2 clinical trial, which evaluated the efficacy and safety of vepdegestrant against fulvestrant in patients who had previously received CDK4/6 inhibitor plus endocrine therapy. The study enrolled 624 patients across 25 countries. Approximately 43% of these patients had detectable ESR1 mutations. The primary measure of the trial was progression-free survival.
Vepdegestrant is a PROTAC (PROteolysis TArgeting Chimera) protein degrader that targets and degrades the estrogen receptor. It has been granted Fast Track designation by the FDA as a monotherapy for adults with advanced or metastatic breast cancer who have previously undergone endocrine-based therapy.
Arvinas, a clinical-stage biotechnology company, is pioneering the development of protein degradation therapies. In July 2021, Arvinas and Pfizer entered into a global collaboration for the co-development and co-commercialization of vepdegestrant, sharing development costs, commercialization expenses, and profits.
The findings from the VERITAC-2 study were presented at the American Society for Clinical Oncology 2025 Annual Meeting and were selected for the ASCO press briefing and for Best of ASCO. They were also concurrently published in The New England Journal of Medicine. According to InvestingPro data, Arvinas’s stock has experienced significant volatility, with the share price currently down 75% over the past year, though analysts have recently revised their earnings expectations upward. The company maintains a strong liquidity position with a current ratio of 4.58, indicating robust short-term financial health.
The FDA’s review of the NDA is a critical step toward potentially making vepdegestrant available as a new treatment option for patients with this form of advanced breast cancer. This information is based on a press release statement from Arvinas, Inc. InvestingPro analysis indicates the company is currently undervalued, with additional insights available through their comprehensive Pro Research Report, which offers deep-dive analysis of over 1,400 US stocks, including Arvinas’s financial health, growth prospects, and market positioning.
In other recent news, Arvinas Inc. has been the subject of significant attention following the release of its Phase 3 VERITAC-2 trial data. The trial results for vepdegestrant (vepdeg) demonstrated a median progression-free survival of five months for ESR1-mutant patients, leading H.C. Wainwright to reaffirm a Buy rating with a $24 price target. However, other analysts have expressed concerns. Leerink Partners downgraded Arvinas to Market Perform with a $9 price target, citing the evolving breast cancer treatment landscape and competition from alternative therapies like AstraZeneca’s camizestrant. Citi also reduced Arvinas’ price target to $9.50, maintaining a Neutral rating, after Pfizer halted certain combination trials involving vepdeg.
Truist Securities followed suit, downgrading Arvinas from a Buy to a Hold and lowering the price target to $11, reflecting concerns over the narrower than expected market for vepdeg. Despite these challenges, BTIG maintained a Buy rating, albeit with a reduced price target of $16, acknowledging Arvinas’ potential in targeting ESR1 mutations. The strategic partnership with Pfizer remains crucial, as both companies adjust their focus to capitalize on promising clinical data. Arvinas continues to explore its pipeline, including early-stage programs in other therapeutic areas, which could influence its future market position.
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