The FDA’s AI Shift Just Created a Huge Opportunity – 6/23

How to Trade the U.S. FDA’s Game-Changing Shift to Artificial Intelligence

Artificial intelligence isn’t just a tech trend anymore — it’s becoming central to how entire industries operate. And one of the biggest shifts is happening right now in U.S. healthcare.

The U.S. Food and Drug Administration (FDA) is preparing to roll out a powerful generative AI model to assist with scientific reviews. According to FDA Commissioner Marty Makary, this system is expected to be deployed across the agency by the end of June.

That’s not just a bureaucratic upgrade — it’s a paradigm shift that could accelerate how quickly new treatments, diagnostics, and drugs are evaluated and approved. And for investors, this marks a major signal: artificial intelligence is no longer just augmenting the healthcare space — it’s starting to reshape it from the inside out.

AI in Healthcare Is Exploding

This regulatory embrace of AI coincides with explosive growth across the healthcare AI sector.

According to Precedence Research, the AI in healthcare market is projected to grow from $26.69 billion in 2024 to $39.96 billion in 2025, before soaring to $613.81 billion by 2034. That’s an increase of more than 2,200% in just a decade.

Why the surge? Simply put, AI is revolutionizing the way the industry operates:

• Faster drug discovery

• More accurate diagnostics

• Personalized treatments

• Streamlined clinical trials

• Reduced administrative burden

With the ability to process and analyze massive datasets, AI can uncover insights that humans alone would miss. That means more effective treatments, quicker approvals, and better outcomes — not just for patients, but for healthcare investors as well.

This new momentum — driven by both technological progress and regulatory adoption — makes certain companies especially attractive right now.

Here are two stocks well-positioned to benefit from this shift.

Company: Recursion Pharmaceuticals (SYM: RXRX)

Recursion Pharmaceuticals is at the forefront of AI-driven drug discovery.

The company combines biology, chemistry, automation, and machine learning to accelerate the identification of new therapies. And it’s already making big moves — particularly through its partnership with pharmaceutical giant Sanofi.

In its most recent earnings update, RXRX announced it had reached the fourth milestone in its Sanofi collaboration, earning a $7 million payment. This milestone was tied to progress on an orally active small-molecule drug with best-in-class potential for treating autoimmune diseases.

This isn’t just a milestone — it’s validation of the company’s approach.

As Recursion’s Chief R&D Officer, Najat Khan, explained:

“Our portfolio evolution reflects Recursion’s commitment to advancing medicines in areas of high unmet need… We are proactively streamlining our portfolio, platform, and operations, making deliberate tradeoffs to focus resources on programs with the strongest scientific rationale and the highest potential for near- and long-term impact.”

In plain terms: Recursion is doubling down on the projects with the biggest potential payoffs, using AI to sharpen its focus and execution.

That’s not just good science — it’s smart business.

With the FDA now embracing AI, companies like Recursion — already using machine learning in partnership with Big Pharma — may soon have a smoother path to approvals and commercialization.

Company: Schrödinger Inc. (SYM: SDGR)

If Recursion is leading the way on AI-powered drug discovery, Schrödinger is revolutionizing how those drugs are designed in the first place.

Schrödinger is a leader in computational molecular modeling — using software to simulate, design, and optimize new molecules before they’re ever tested in a lab. Its platforms allow scientists to model the behavior of molecules digitally, saving enormous time and resources compared to traditional R&D.

Key products include:

• Maestro – an intuitive interface for molecular modeling

• LiveDesign – for real-time collaboration and molecule design

• FEP+ – predictive software that calculates the binding affinity of molecules

• Glide – a tool for virtual screening of potential drug compounds

This isn’t theoretical science — it’s already being used in real-world drug development.

Schrödinger’s platform helps pharmaceutical companies identify promising drug candidates faster, with a higher probability of success. As AI becomes more central to the FDA’s review process, tools like Schrödinger’s — which already generate data at a high standard — are likely to become even more valuable.

Moreover, the scalability of Schrödinger’s software means its addressable market is broad — not just biotech and pharma, but also materials science and industrial chemistry.

With the regulatory winds shifting in favor of AI, Schrödinger stands to benefit on multiple fronts.