AI Triggers Biotech's Largest Surge Since 2004 — Why Is It Going Unnoticed?
AI's Impact on Biotech Stocks: The biotech sector is experiencing a significant rally, with the iShares Biotechnology ETF rising for six consecutive months and achieving a 40% increase, marking its best performance since 2003, driven by AI's role in improving drug development efficiency.
Transformation in Drug Discovery: AI is revolutionizing the traditionally slow and costly drug discovery process, shifting from labor-intensive methods to compute-driven approaches, which promise faster, cheaper, and more predictable outcomes in pharmaceutical research and development.
Investor Skepticism and Future Potential: Despite ongoing skepticism from some investors regarding AI's valuation and market impact, experts believe that AI could unlock significant advancements in healthcare, including longer lifespans and more effective treatments, fundamentally changing the industry's landscape.
Implementation Phase of AI in Biotech: The transition from AI research to practical implementation is underway, with companies like Moderna and Eli Lilly actively utilizing AI to enhance drug development processes, indicating a shift towards a more efficient and scalable biotech industry.
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- Strong Stock Performance: Moderna's shares have surged 39% in 2026, despite the absence of recent financial results, indicating market confidence in its future potential ahead of the upcoming Q4 2025 earnings report.
- Pipeline Candidate Progress: The combination of mRNA-4157 and Merck's Keytruda has shown a significant reduction in disease recurrence or death in advanced melanoma patients, bolstering investor confidence in Moderna's cancer vaccine prospects, which could become a vital revenue source.
- Influenza Vaccine Submission: Moderna has submitted its mRNA-1010 influenza vaccine candidate for approval targeting adults aged 50 and older, expected to address the low efficacy issues in the flu vaccine market, particularly benefiting elderly patients.
- Declining Revenue Expectations: While Moderna anticipates revenue between $1.6 billion and $2 billion for 2025, the regulatory pressures in the coronavirus vaccine market may lead to declining sales, highlighting the challenges and opportunities the company faces during its transformation.

Moderna's Stock Reaction: Moderna's shares dropped by 11.5% following the refusal of the U.S. Food and Drug Administration (FDA) to review the company's influenza vaccine application.
FDA's Decision Impact: The FDA's decision not to review the influenza vaccine application has raised concerns about the future of Moderna's vaccine development efforts.
- FDA Refusal: The FDA has declined to consider the approval of Moderna's new flu vaccine.
- Impact on Public Health: This decision may affect the availability of new flu vaccination options for the upcoming flu season.

Regulatory Update: Moderna has received a refusal letter from the U.S. Food and Drug Administration regarding its investigational seasonal influenza vaccine, mRNA-1010.
Vaccine Details: The vaccine is designed to target multiple strains of the influenza virus, but the FDA's decision indicates concerns that need to be addressed before moving forward.
- Inflation Data Release: The January Consumer Price Index (CPI) is set to be released on February 13, with economists expecting the headline CPI to remain at 0.3% while core CPI rises from 0.2% to 0.3%, potentially influencing the Fed's rate decisions.
- Moderna Earnings Outlook: Moderna is scheduled to report its fourth-quarter results on Friday, with analysts anticipating the company to reaffirm its sales growth outlook of about 10% for 2026, although questions about the durability of this outlook may affect investor confidence.
- Wendy's Sales Forecast: Wendy's is projecting a decline in same-store sales in the high single digits for Q4, primarily due to tougher comparisons from last year and promotional activities, which could pressure the company in the competitive fast-food market.
- Enbridge Financial Forecast: Enbridge expects its fourth-quarter EBIDA to remain flat year-over-year, keeping it near the upper end of its full-year guidance range, with investors keen on updates regarding cash flow growth in 2026 and the impact of currency dynamics on its outlook.
- Vaccine Application Rejection: The FDA's refusal to review Moderna's flu vaccine application mRNA-1010, citing inadequate trial design, caused the stock to drop over 3% in a single trading session, putting pressure on the company's short-term growth outlook.
- Market Performance Review: Moderna's stock soared over 700% in 2020, with vaccine sales exceeding $18 billion in 2022; however, as pandemic demand waned, the company had to implement cost cuts and realign its pipeline towards seasonal vaccines and oncology opportunities.
- R&D Progress and Challenges: While Moderna has made strides in oncology and rare disease therapeutics, its cytomegalovirus vaccine candidate failed in a phase 3 trial, highlighting the uncertainties in its R&D efforts that could impact future revenue streams.
- Long-Term Growth Potential: Despite facing near-term challenges, Moderna's mRNA technology holds significant long-term growth potential, and if the company can launch new products in the coming years, it may enter a new era of growth, making it an attractive buy for investors during this dip.





