Arvinas (ARVN) stock rises on FDA submission with Pfizer (PFE)

Investing.com -- Shares of Arvinas Inc (NASDAQ: ARVN) climbed 1.6% while Pfizer Inc (NYSE: PFE) edged up 0.5% following the announcement of a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). The NDA, submitted jointly with Pfizer, is for vepdegestrant, a potential new treatment for ER-positive/HER2-negative ESR1-mutated advanced or metastatic breast cancer.

The application is based on the Phase 3 trial results from VERITAC-2, which compared the efficacy of vepdegestrant against fulvestrant. John Houston, Ph.D., CEO of Arvinas, expressed optimism about the review process after presenting the findings at the American Society of Clinical Oncology's annual meeting. Vepdegestrant has been recognized with fast track designation by the FDA and is being co-developed by Arvinas and Pfizer.

The recent developments follow the presentation of the VERITAC-2 study at the prestigious ASCO 2025 Annual Meeting, where it was featured in a late-breaking oral session and selected for an ASCO press briefing. The study's results were also published in the New England Journal of Medicine, highlighting the potential impact of vepdegestrant as the first FDA-approved PROTAC ER degrader, offering a novel treatment avenue for patients with advanced breast cancer.

The submission of the NDA marks a significant step for both companies, as they aim to bring a new therapeutic option to a patient population in need of alternative treatments. The market's positive reaction reflects investor confidence in the potential approval and future commercial success of vepdegestrant.

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