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SpringWorks Therapeutics Nears EU Approval for First Desmoid Tumor Therapy, Nirogacestat

SpringWorks Therapeutics Inc. (NASDAQ:SWTX) is one of the best biotech stocks to invest in now. On June 20, SpringWorks Therapeutics announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use/CHMP adopted a positive opinion recommending the approval of nirogacestat. The oral gamma secretase inhibitor is proposed as a monotherapy for adults with progressing desmoid tumors who require systemic treatment.

The European Commission/EC is expected to review the CHMP opinion and make a decision regarding approval in Q3 2025. If approved, nirogacestat will be the first and only therapy with marketing authorization in the European Union for desmoid tumors. Nirogacestat previously received Orphan Drug designation from the EC for soft tissue sarcoma. The positive CHMP opinion was based on the Marketing Authorization Application/MAA for nirogacestat, which utilized results from the Phase 3 DeFi trial.

A closeup of a scientist in a lab coat, mixing two liquids for a compound to treat rare diseases.

The results were published in The New England Journal of Medicine. In the DeFi trial, nirogacestat met its primary endpoint by improving progression-free survival/PFS, which showed a 71% lower risk of disease progression compared to placebo. The trial also showed a significant improvement in objective response rate and early, sustained improvements in patient-reported outcomes, including pain, physical functioning, and overall quality of life. The safety and tolerability profile of nirogacestat was manageable.

SpringWorks Therapeutics Inc. (NASDAQ:SWTX) is a commercial-stage biopharmaceutical company that develops and commercializes medicines for underserved patient populations suffering from rare diseases and cancer.

While we acknowledge the potential of SWTX 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.

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

Dr. Inan Dogan

Dr. Ian Dogan

Co-Founder and Research Director at Insider Monkey

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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Dr. Inan Dogan

Dr. Ian Dogan

Co-Founder and Research Director at Insider Monkey

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