FDA accepts vepdegestrant NDA for ESR1-mutated breast cancer

NEW HAVEN - The U.S. Food and Drug Administration has accepted the New Drug Application for vepdegestrant, an investigational treatment for patients with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who have previously received endocrine-based therapy. The development marks another potential breakthrough for Pfizer Inc., a prominent player in the pharmaceuticals industry with a substantial market capitalization of $140 billion and impressive gross profit margins of nearly 74%.

Arvinas, Inc. (NASDAQ:ARVN) and Pfizer Inc. (NYSE:PFE) announced today that the FDA has assigned a Prescription Drug User Fee Act action date of June 5, 2026, for the application.

The NDA submission is based on data from the Phase 3 VERITAC-2 clinical trial, which demonstrated statistically significant and clinically meaningful improvement in median progression-free survival compared to fulvestrant. The trial results were recently presented at the American Society of Clinical Oncology 2025 Annual Meeting and published in The New England Journal of Medicine. According to InvestingPro analysis, Pfizer’s strong financial health score and current undervalued status suggest significant potential for growth from this and other pipeline developments. InvestingPro subscribers have access to detailed analysis of Pfizer’s extensive drug pipeline and its impact on future earnings.

Vepdegestrant is an oral PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader, the first of its class to demonstrate clinical benefit in patients with breast cancer, according to the company’s press release.

"Patients often face limited treatment options after first-line treatment and vepdegestrant demonstrated improved progression-free survival in patients with ESR1-mutated ER+/HER2- advanced breast cancer," said John Houston, Ph.D., Chairperson, Chief Executive Officer, and President at Arvinas.

The global Phase 3 VERITAC-2 trial enrolled 624 patients at 213 sites across 25 countries, with 270 patients having ESR1 mutations. Participants were randomized to receive either oral vepdegestrant daily or intramuscular fulvestrant.

The FDA has previously granted Fast Track designation to vepdegestrant, highlighting the unmet need in this patient population.

Arvinas and Pfizer are jointly developing vepdegestrant under a global collaboration announced in July 2021, with both companies sharing worldwide development costs, commercialization expenses, and profits. With Pfizer’s robust annual revenue of $63.8 billion and strong cash flow generation, the company is well-positioned to support this collaboration. InvestingPro research reveals multiple additional positive indicators for Pfizer’s future performance, with detailed insights available in the comprehensive Pro Research Report, one of 1,400+ deep-dive analyses available to subscribers.

In other recent news, Pfizer Inc. reported stronger-than-expected earnings for the second quarter of 2025. The company posted an earnings per share (EPS) of $0.78, significantly surpassing the analyst forecast of $0.57, marking a 36.84% surprise. Revenue also exceeded expectations, reaching $14.7 billion compared to the anticipated $13.47 billion. In light of these results, Morgan Stanley raised its price target for Pfizer stock from $32.00 to $33.00, maintaining an Equalweight rating. This adjustment follows Pfizer’s recent earnings report, which provided insights into the evolving biopharmaceutical policy landscape. These developments highlight the company’s strong financial performance and potential growth in the near term.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.