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Dear Fellow Investor,
How to Trade the U.S. FDA’s Shift to Artificial Intelligence
Artificial intelligence is no longer a futuristic concept—it’s an active force reshaping entire industries, and nowhere is that more apparent than in healthcare.
The U.S. Food and Drug Administration (FDA) is preparing to roll out a generative AI model across the agency, designed to enhance scientific reviews and regulatory decision-making. According to FDA Commissioner Marty Makary, the tool is expected to be deployed agency-wide by the end of June 2025.
This development marks a major step forward in the integration of artificial intelligence into regulatory workflows, and it could have ripple effects across the broader healthcare and biotech sectors. For investors, it also presents a compelling opportunity.
Why the FDA’s Move Matters
The FDA plays a central role in approving new drugs, medical devices, diagnostics, and therapies—a process that can be slow, complex, and expensive. Incorporating AI into that framework could help speed up drug reviews, improve accuracy, and reduce bottlenecks.
With this generative AI rollout, the FDA is signaling its belief in the transformational power of AI, not just for research and development (R&D), but also for policy enforcement, data review, and decision support. As AI takes over more administrative and analytical functions, expect regulatory approval timelines to compress—unlocking faster go-to-market strategies for innovative therapies.
That’s not just good for patients—it’s also a potential tailwind for AI-focused healthcare companies.
AI in Healthcare: A Massive Growth Market
According to Precedence Research, the global AI-in-healthcare market was valued at approximately $26.69 billion in 2024, is projected to hit $39.96 billion in 2025, and could surge to $613.81 billion by 2034. That’s a staggering compound annual growth rate (CAGR), driven by:
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The increasing digitization of healthcare systems
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Rising volumes of clinical data
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Growing demand for personalized medicine
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Accelerated drug discovery initiatives
AI is already transforming healthcare by enabling faster, more accurate diagnostics, reducing human error, personalizing treatments, optimizing clinical trials, and cutting R&D costs. With the FDA now pushing AI integration at the regulatory level, that growth trajectory could steepen even further.
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Top AI Healthcare Stocks to Watch
If you're looking to position your portfolio to capitalize on this trend, here are two companies at the forefront of AI-driven drug development and molecular discovery.
Company: Recursion Pharmaceuticals (SYM: RXRX)
Market Cap: ~$1.5 billion (as of early 2025)
Sector: Biotechnology / AI Drug Discovery
Recursion Pharmaceuticals is one of the most promising players using AI to unlock new possibilities in drug development. The company’s proprietary platform combines automated laboratories with machine learning algorithms to analyze biological images and uncover insights into cellular behavior—essentially creating a “search engine” for drug discovery.
Most recently, RXRX achieved a key milestone in its collaboration with Sanofi, earning a $7 million payment for advancing an orally active small-molecule lead for autoimmune diseases. This is the fourth milestone hit under the partnership, which validates Recursion’s platform and its ability to drive results at scale.
In a recent statement, Chief R&D Officer Najat Khan emphasized Recursion’s commitment to streamlining operations and prioritizing high-impact programs:
“We are making deliberate tradeoffs to focus resources on programs with the strongest scientific rationale and the highest potential for near- and long-term impact.”
RXRX’s upcoming merger with Exscientia—another AI-driven biotech firm—adds further depth to its platform and global reach. The company is well-positioned to benefit not only from growing demand for AI-enhanced drug discovery but also from the FDA’s accelerated embrace of automation and data science.
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Company: Schrödinger (SYM: SDGR)
Market Cap: ~$2.2 billion (as of early 2025)
Sector: Computational Chemistry / Biotech Software
Schrödinger is revolutionizing molecular research through its powerful computational platform, which helps pharmaceutical and materials science companies simulate and predict molecular behavior with a high degree of accuracy.
Rather than relying solely on lab-based experimentation, SDGR enables scientists to test how molecules might perform in silico (in a virtual environment). This drastically reduces the time and cost required to develop new drugs—and helps zero in on more promising candidates earlier in the pipeline.
Key products include:
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Maestro: A modeling and visualization environment
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LiveDesign: Collaborative molecular design tool
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FEP+: Predicts ligand binding affinities
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Glide: Enables high-throughput virtual screening
With the FDA moving toward deeper AI integration, tools like Schrödinger’s are likely to become essential. Drug developers will increasingly rely on simulation platforms to submit better data, faster—aligning perfectly with the FDA’s new review protocols.
Schrödinger is already working with several top-20 pharmaceutical companies, and as more firms digitize their discovery workflows, SDGR stands to benefit significantly.
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Are there any other AI/Biotech stocks you've got your eye on? What other sectors of the market do you think are the best places to put your money to work right now? Hit "reply" to this email and let us know your thoughts!
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