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Moderna, Inc. (MRNA) Withdraws Application for COVID-flu Combination Vaccine

Moderna, Inc. (NASDAQ:MRNA) today announced that it had voluntarily withdrawn the pending Biologics License Application (BLA) seeking approval for its COVID-19 and Influenza combination vaccine for adults aged 50 years and older.

In a brief press release on Wednesday, the company said that it had decided after consultation with the FDA. Moderna, Inc. (NASDAQ:MRNA) plans on resubmitting the application later in the year, after it receives efficacy data from an ongoing trial of its influenza shot, mRNA-1010.

A scientist surrounded by vials and beakers in a modern laboratory, proudly displaying a vaccine.

The delay comes as no surprise, given Moderna, Inc. (NASDAQ:MRNA)’s statement earlier in the month about the company not anticipating approval of the shot until 2026. However, experts view the pullback as yet another sign of America’s increased regulatory scrutiny of the vaccine approval process.

On May 20, the FDA tightened COVID-19 vaccine requirements by stating that it plans to require new trials for approval of annual booster shots for healthy Americans aged under 65, effectively limiting the usage to older adults and those at risk of severe illnesses.

Moderna, Inc. (NASDAQ:MRNA) made a name for itself by quickly developing an effective coronavirus vaccine when the world needed it the most. However, the stock has largely struggled since the pandemic started to recede. The company has also been affected by increased regulatory scrutiny and a volatile political environment.

Shares had plunged by 8% as of 2 PM EDT on Wednesday, taking the year-to-date slump to 38%.

While we acknowledge the potential of MRNA as an investment, 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 MRNA and that has 100x upside potential, check out our report about this cheapest AI stock.

READ NEXT: ChatGPT Stock Advice: Top 12 Stock Recommendations and 10 Cheap Rising Stocks to Buy Right Now.

Disclosure: None.

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.

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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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