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FDA Accepts Bristol Myers Squibb (BMY) NDA for Iberdomide With Priority Review

Bristol-Myers Squibb Company (NYSE:BMY) is one of the best value stocks to buy now. On February 17, Bristol Myers Squibb announced that the FDA accepted its NDA for iberdomide, which is an investigational treatment for patients with relapsed or refractory multiple myeloma/RRMM. If approved, iberdomide would become the first in a new class of oral medicines known as cereblon E3 ligase modulator agents. The FDA granted the application Priority Review and Breakthrough Therapy Designation, setting a target action date of August 17 this year.

The application is supported by data from the Phase 3 EXCALIBER-RRMM trial, which compared iberdomide in combination with daratumumab and dexamethasone against a standard three-drug regimen. A key highlight of this filing is the use of Minimal Residual Disease/MRD negativity as a primary endpoint. MRD measures the tiny number of cancer cells remaining in the body that traditional tests cannot find; achieving MRD negativity is a highly sensitive indicator that a treatment is effectively clearing the disease and may predict longer periods of remission.

Pixabay/Public domain

Iberdomide works through targeted protein degradation, a process where the drug tags specific cancer-promoting proteins for destruction by the cell’s internal recycling system. This approach builds on Bristol-Myers Squibb Company’s (NYSE:BMY) long-standing history with immunomodulatory drugs, aiming to provide a more potent oral option with a manageable safety profile.

Bristol-Myers Squibb Company (NYSE:BMY) discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide.

While we acknowledge the potential of BMY 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 BMY and that has a 100x upside potential, check out our report about the cheapest AI stock.

READ NEXT: 10 Most Profitable Undervalued Stocks to Buy and 11 Best Mining Stocks to Buy According to Wall Street.

Disclosure: None.

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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

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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.

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  • 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.

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