Part of Moderna
American pharmaceutical and biotechnology company based in Cambridge, Massachusetts, focused on RNA therapeutics, primarily mRNA vaccines; has commercial vaccines for COVID-19, RSV, and influenza, with dozens of additional candidates in development.
Clinical Trials
159
45 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2010
Active, not recruiting
42
26.4%
Completed
79
49.7%
Not yet recruiting
3
1.9%
Recruiting
25
15.7%
Terminated
6
3.8%
Unknown
1
0.6%
Withdrawn
3
1.9%
No approval data available
- Moderna will present full Phase 3 data for its mRNA-based individualized neoantigen therapy intismeran autogene at ESMO Congress 2026 in Madrid on October 24. - The INTerpath-001 trial tested intismeran plus pembrolizumab versus pembrolizumab alone in resected stage IIB-IV melanoma and met its primary endpoint. - Recurrence-free survival is the primary endpoint, and the hazard ratio remains the key missing metric for assessing the magnitude and durability of benefit. - Two additional abstracts cover adjuvant intismeran plus FOLFIRINOX in resectable pancreatic ductal adenocarcinoma and the Phase 3 INTerpath-014 trial in resected high-risk stage I NSCLC.
- The EPO Boards of Appeal revoked EP 3 590 949, a Moderna mRNA vaccine patent that had been upheld at first instance. - Board of Appeal 3.3.08 issued the decision after a two-day oral hearing, with added matter cited as a likely factor. - The ruling removes patent grounds Moderna had used against BioNTech and Pfizer, though divisional applications and further litigation remain.
- Novartis's pelacarsen and Novo Nordisk's ziltivekimab both failed to separate from placebo in late-stage cardiovascular outcome trials despite strong genetic support for their targets. - Cardiologist Ethan Weiss said the field can no longer claim that genetics is undefeated in predicting which drugs will work in outcome studies. - Novartis shares fell 14% in a single session and Amgen dropped 9.8% as investors repriced roughly 35,000 patients still enrolled in Lp(a) outcome trials. - Weiss attributed the Lp(a) failure largely to background therapy, arguing the risk signal diminishes in patients already on statins and other powerful medicines.
- At the TIME100 Health Leadership Forum in New York, oncology experts named vaccines, immunotherapy, early detection and prevention as the most promising fronts in cancer research. - American Cancer Society CEO Shane Jacobson credited philanthropic and federal funding for rapid innovation, citing Moderna and Merck's encouraging mRNA cancer vaccine results. - Memorial Sloan Kettering oncologist Andrea Cercek cited a 2024 rectal cancer study in which no patient had detectable tumors after six months of immunotherapy. - Cercek said she is 'very close' to extending this immunotherapy approach to other cancers, and predicted early detection and prevention will ultimately cure cancer.
- The FDA approved Moderna's mFLUSIVA in August 2026, making it the first seasonal influenza vaccine in the US to use mRNA-based production. - In a phase 3 trial of more than 40,000 adults aged 50 and older, 2% of mFLUSIVA recipients developed flu illness versus 2.8% on a standard-dose vaccine. - mFLUSIVA encodes full-length hemagglutinin from three WHO-recommended influenza strains delivered by lipid nanoparticles, and the 2026-27 formula contains no egg protein. - About 75% of mFLUSIVA recipients reported at least one expected short-term reaction compared with 47% of standard-dose vaccine recipients, with most reactions mild or moderate.
- Merck is building its next growth phase around a phase III pipeline that has nearly tripled since 2021 and a target of 20 new drug launches by 2030. - The company projects more than $70 billion in non-risk-adjusted commercial opportunity from its current pipeline by the mid-2030s, more than double Keytruda's $35 billion peak consensus estimate. - Merck and Moderna reported the first positive phase 3 result for a personalized mRNA cancer vaccine, though detailed efficacy and overall survival data remain pending. - Management expects the Keytruda loss-of-exclusivity period to resemble a shallow dip or hill with a quick return to growth rather than a revenue cliff.
- BioNTech and Genentech terminated the Phase II BNT122-01 trial of autogene cevumeran in resected colorectal cancer after a DSMB found an overall survival imbalance favoring the control arm. - The DSMB had previously flagged futility in October 2025 but allowed the trial to continue, concluding the data were too immature for reliable efficacy conclusions. - No new safety signals were identified, and the pancreatic cancer program IMcode003 testing autogene cevumeran with atezolizumab and mFOLFIRINOX continues as planned. - The result reinforces questions about personalized mRNA vaccines in immunologically cold, microsatellite stable tumors without checkpoint inhibitor support.
- An Army doctor testified in federal court that she is examining 2,544 unverified deaths among service members reported to HHS's Vaccine Adverse Event Reporting System (VAERS). - Theresa Long, senior medical military adviser to Health Secretary Robert F. Kennedy Jr., said she knows of 28 people who died from the COVID-19 vaccine but was not permitted to share more details. - Long's Aug. 14 deposition, obtained by Politico, came in a lawsuit over the CIA's dismissal of Terry Adirim, who alleges she was fired for her advocacy of COVID-19 vaccination. - The testimony highlights ongoing scrutiny of COVID-19 vaccine safety, though a 2022 study found 38 deaths could have been related to the vaccine after more than 8 billion doses were administered.
- South Korean and U.S. healthcare experts urged regulatory reforms aligned with global standards to support sustainable growth and improve patient care at an AMCHAM seminar in Seoul. - Local doctors emphasized that precision diagnostics and treatment, including genome testing for advanced lung cancer patients, are urgently needed but currently hindered by regulatory barriers. - Experts called for legislation specifically addressing corneal transplants, noting that access is restricted by regulations treating corneas like other human tissue. - The government pledged to shorten reimbursement approval times for rare disease treatments and strengthen outcomes-based value assessments.
- Australia is vaccinating 5,000 little penguins on Phillip Island against H5N1 using the Zoetis H5N2-subtype killed-virus vaccine, not an mRNA product. - Veterinary and agriculture officials confirmed the inactivated vaccine contains no live virus and cannot cause disease or replicate in recipients. - The unprecedented rollout follows Australia's first H5N1 detection in June 2026 and 484 confirmed H5 wildlife events as of September 4. - Vaccine scientists say no scientific data supports claims that mRNA vaccines are inherently harmful or capable of altering a recipient's genome.
