Arvinas, Pfizer's Vepdegestrant NDA Accepted by FDA for Breast Cancer Treatment

Arvinas Inc. (NASDAQ:ARVN) is one of the best small cap stocks with biggest upside potential. On August 8, Arvinas, in collaboration with Pfizer Inc. (NYSE:PFE), announced that the US FDA accepted its New Drug Application/NDA for vepdegestrant. The drug is intended to treat patients with estrogen receptor-positive/ER+, human epidermal growth factor receptor 2-negative/HER2-, ESR1-mutated advanced or metastatic breast cancer who have already received endocrine-based therapy.

The FDA has set a Prescription Drug User Fee Act/PDUFA action date of June 5, 2026. The NDA is based on data from the Phase 3 VERITAC-2 clinical trial, which showed a statistically significant and clinically meaningful improvement in median progression-free survival for vepdegestrant compared to fulvestrant. The trial enrolled 624 patients at 213 sites across 25 countries, with 270 of these patients having the ESR1 mutation.

The results from this trial were recently presented at the American Society of Clinical Oncology/ASCO 2025 Annual Meeting and published in The New England Journal of Medicine. Vepdegestrant is an investigational oral drug that functions as a PROteolysis TArgeting Chimera/PROTAC estrogen receptor degrader. This marks the first time a PROTAC has demonstrated a clinical benefit in breast cancer patients.

Arvinas Inc. (NASDAQ:ARVN) is a clinical-stage biotechnology company that engages in the discovery, development, and commercialization of therapies to degrade disease-causing proteins.

Pfizer Inc. (NYSE:PFE) discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products in the US and internationally.

While we acknowledge the potential of ARVN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

Disclosure: None. This article is originally published at Insider Monkey.