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 initial rejection of Moderna's mRNA flu vaccine, agreeing to a normal review after public backlash, while a federal judge invalidated the ACIP advisory committee, leaving the US without functioning vaccine oversight. Moderna's vaccine showed 26.6% greater efficacy than standard flu shots in clinical trials.
An FDA advisory panel unanimously recommended approval of Moderna's mRNA flu vaccine mFlusiva for adults 50 and older. The vaccine showed a 27% reduction in flu cases versus a standard shot. A final FDA decision is expected by early August.
Personalized mRNA vaccines showed promise in pancreatic cancer trials with 7 of 16 patients in remission after five years. Stage 2 melanoma patients saw a 50% decreased death risk with personalized mRNA vaccines. U.S. funding cuts and policy shifts have stalled domestic mRNA cancer research while companies move trials abroad.
Long-term data from ASCO 2026 shows the personalized cancer vaccine Intismeran Autogene, combined with Keytruda, reduces recurrence or death risk by 49% in high-risk melanoma patients. Developed by MSD and Moderna, the vaccine uses AI to select neoantigens from a patient's tumor and mRNA technology to create a personalized treatment. The results signal a major advance for a field that had struggled for decades, spurring similar development efforts by other companies.
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.
| 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 |
