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FDA Approves Bristol-Myers Squibb’s Breyanzi as First-Ever CAR T Therapy for Rare Marginal Zone Lymphoma

Bristol-Myers Squibb Company (NYSE:BMY) is one of the best stocks to buy for the next 5 years. On December 15, Goldman Sachs raised the firm’s price target on Bristol-Myers Squibb to $57 from $51, while maintaining a Neutral rating on the shares.

Earlier on December 4, Bristol-Myers Squibb announced that the US FDA approved Breyanzi (lisocabtagene maraleucel) for adult patients with relapsed or refractory (R/R) marginal zone lymphoma/MZL. This approval specifically applies to patients who have already received at least two prior lines of systemic therapy. With this milestone, Breyanzi becomes the first and only CAR T cell therapy approved for this patient population, and it now holds the record as the only CD19-directed CAR T therapy approved for five distinct types of B-cell malignancies.

The FDA’s decision was based on results from the MZL cohort of the TRANSCEND FL study, which demonstrated deep and durable responses. In the primary efficacy analysis of 66 patients, Breyanzi achieved an overall response rate of 95.5%, with 62.1% of patients reaching a complete response. The treatment showed remarkable longevity; while the median duration of response has not yet been reached, 90.1% of responders maintained their response at the 24-month mark. The therapy is administered as a one-time infusion and is designed for both inpatient and outpatient settings due to its established safety profile.

Safety data from the trial remained consistent with previous Breyanzi studies. The product carries Boxed Warnings regarding CRS, neurologic toxicities, and the potential for secondary hematological malignancies. Beyond MZL, Breyanzi is already approved for large B-cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, follicular lymphoma, and mantle cell lymphoma.

Bristol-Myers Squibb Company (NYSE:BMY) discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. It offers products for oncology, hematology, immunology, cardiovascular, neuroscience, and other areas.

While we acknowledge the potential of BMY 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 BMY 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.

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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Wall Street calls this $3 stock a “Melting Ice Cube.” They said the same thing about BTI before it returned 90%.

Dr. Inan Dogan

Dr. Ian Dogan

Co-Founder and Research Director at Insider Monkey

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We looked under the cover and realized they were wrong.

We alerted our subscribers, and BTI returned 90% in just 16 months.

Now if you had invested just $10,000 in BTI in June 2024, you’d be sitting on $19,000 in October 2025.

Today, we have identified a nearly identical pattern in a digital-first giant trading at $3.

While the market panics over a surface-level revenue decline, our PhD-led research shows management has actually surgically cut $100 million in waste to focus on high-margin growth.

This pattern is a hallmark of our 16.5% annual return track record. The current opportunity offers a 400% upside potential—dwarfing even our 90% BTI return.

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