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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.

A biopharma executive in a meeting room discussing the clinical-stage of a new therapy.

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 to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than ARVN and that has 100x upside potential, check out our report about this cheapest 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.

The $250 Trillion AI Hype is Real. A few years from now, you’ll probably wish you’d bought this stock.

When Jeff Bezos said that one breakthrough technology would shape Amazon’s destiny, even Wall Street’s biggest analysts were caught off guard.

Fast forward a year and Amazon’s new CEO Andy Jassy described generative AI as a “once-in-a-lifetime” technology that is already being used across Amazon to reinvent customer experiences.

At the 8th Future Investment Initiative conference, Elon Musk predicted that by 2040 there would be at least 10 billion humanoid robots, with each priced between $20,000 and $25,000.

Do the math. According to Musk, this technology could be worth $250 trillion by 2040.

Put another way, that’s roughly equal to:

  • 175 Teslas
  • 107 Amazons
  • 140 Metas
  • 84 Googles
  • 65 Microsofts
  • And 55 Nvidias

And here’s the wild part — this $250 trillion wave isn’t tied to one company, but to an entire ecosystem of AI innovators set to reshape the global economy.

It’s a leap so massive, it could reshape how businesses, governments, and consumers operate worldwide.

Even if that $250 trillion figure sounds ambitious, major firms like PwC and McKinsey still see AI unlocking multi-trillion-dollar potential.

How could anything be worth that much?

The answer lies in a breakthrough so powerful it’s redefining how humanity works, learns, and creates.

And this breakthrough has already set off a frenzy among hedge funds and Wall Street’s top investors.

What most investors don’t realize is that one under-owned company holds the key to this $250 trillion revolution.

In fact, Verge argues this company’s supercheap AI technology should concern rivals.

Before I reveal the details, let’s talk about how some of the richest people on the planet are positioning themselves.

  • Bill Gates sees artificial intelligence as the “biggest technological advance in my lifetime,” more transformative than the internet or personal computer, capable of improving healthcare, education, and addressing climate change.
  • Larry Ellison — through Oracle, is spending billions on Nvidia chips and partnering with Cohere to embed generative AI across Oracle’s cloud and apps.
  • Warren Buffett — not known for tech hype — says this breakthrough could have a ‘hugely beneficial social impact.

When billionaires from Silicon Valley to Wall Street line up behind the same idea — you know it’s worth paying attention to.

Even as we admire what Tesla, Nvidia, Alphabet, and Microsoft have built, we believe an even greater opportunity lies elsewhere…

But the real story isn’t Nvidia — it’s a much smaller company quietly improving the critical technology that makes this entire revolution possible.

And judging by what I’m hearing from both Silicon Valley insiders and Wall Street veterans…

This prediction might not be bold at all:

A few years from now, you’ll wish you’d owned this stock.

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