Also known as: Moderna, Moderna Inc, Moderna Inc.
Moderna is a biotechnology company focused on mRNA medicines. The company says it is delivering the greatest possible impact through mRNA medicines and has built one of the industry's leading mRNA technology platforms since its founding in 2010.
The FDA reversed its refusal to review Moderna’s mRNA flu vaccine application and accepted a revised filing with split age cohorts and a post-market study for adults over 65. The reversal came amid broader vaccine regulatory uncertainty and industry concern about unpredictable review timelines.
The S&P 500 has swung to a loss for the year as volatility, geopolitical strains and profit-taking weigh on large-cap stocks. SanDisk, Venture Global and Moderna were among the top gainers.
Vanguard increased its Moderna stake by 1.0% in the fourth quarter to 41.6 million shares worth $1.23 billion. Other institutional investors also adjusted positions, while 75.33% of the stock is held by institutions and hedge funds.
A phase 3 trial of an mRNA H5N1 bird flu vaccine is recruiting 4,000 volunteers in the UK and US. The Moderna-sponsored study aims to assess immune responses against emerging strains as the virus continues to evolve in mammals.
Moderna shares rose after the company reported quarterly results that beat earnings and revenue estimates. The stock move came as investors also weighed an FDA refusal-to-file for its mRNA flu vaccine and ongoing funding concerns.
Moderna reported Q4 2025 revenue of $678 million, down 30%, and a net loss of $826 million, improved from a $1.1 billion loss a year earlier. The company also issued 2026 revenue and expense targets.
mRNA cancer vaccines showed promising pancreatic cancer trial results and boosted tumor-fighting drugs in other research. U.S. officials canceled $500 million in vaccine funding, while the NCI is backing a $200 million cancer vaccine partnership.
The UK has begun a 4,000-volunteer H5N1 bird flu vaccine trial using mRNA technology. The study will assess safety and immune response, with CEPI providing £40m in funding.
The FDA plans to make one study the default for some new drug approvals instead of two robust clinical trials. The shift could have its biggest effect on drugs for common ailments.
NVIDIA and Eli Lilly announced a $1 billion AI co-innovation lab as AI drug discovery expands across research, trials and manufacturing. Companies including Recursion and Tempus are using large biological and clinical datasets to speed development and support precision medicine.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05668741 |
A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF) |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
