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Aug 21, 2026
Moderna and Merck's personalized mRNA cancer vaccine, intismeran autogene, showed promising Phase 3 results in preventing melanoma recurrence. Combined with Keytruda, it cut recurrence risk by half and reduced spread by 59% in earlier data. The treatment could reach patients within two years pending regulatory approval.
Aug 08, 2026
FDA approved Moderna's mFLUSIVA, the first mRNA-based flu vaccine for adults 50+. It was 27% more effective than standard flu shots in a large trial. The approval came after earlier FDA pushback.
Aug 09, 2026
The FDA approved Moderna's mFlusiva, the first mRNA-based flu vaccine, for adults 50 and older. Full approval covers ages 50-64; accelerated approval covers 65+. Moderna expects availability later this year, pending CDC recommendation.
Aug 02, 2026
Moderna reported a second-quarter loss of $782 million and a first-quarter loss of $1.34 billion, both beating expectations. The company appointed a new Chief Commercial Officer ahead of vaccine launches and disclosed CFO restricted stock unit transactions.
Jul 25, 2026
The FDA has refused to file Moderna's flu vaccine candidate mRNA-1010. The company will push forward outside the U.S. and pause its combination flu vaccine, while expressing disappointment over the decision's regulatory implications.
Jun 11, 2026
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.
May 13, 2026
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.
May 03, 2026
mRNA medicine and spatiotemporal drug delivery systems are expanding options for cardiovascular disease. The sources describe preclinical proof-of-concept, clinical trials and programmable cardiac repair platforms.
Apr 22, 2026
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.
Mar 28, 2026
Moderna shares declined nearly 6% amid extreme options market volatility and a new patent infringement lawsuit from BioNTech. The company faces significant financial challenges with negative earnings and declining revenue growth, while valuation metrics suggest potential overvaluation. Technical indicators point to bearish short-term momentum as the stock approaches key support levels.
Mar 12, 2026
Multiple institutional investors modified their Moderna Inc positions during recent quarters, with some funds increasing stakes while others reduced or exited positions, according to 13F filings.
Mar 04, 2026
Moderna has settled with Arbutus and Genevant, facing a potential $1.3 billion liability contingent on Federal Circuit's decision. Multiple institutional investors have increased their stakes in the biotech company during recent quarters.
Feb 26, 2026
The FDA agreed to review Moderna's mRNA-1010 seasonal flu vaccine after initially refusing to file the application, setting a decision date of August 5, 2026. If approved, it would be the first mRNA-based seasonal influenza vaccine on the market.
Feb 24, 2026
The FDA reversed its decision to reject Moderna's mRNA influenza vaccine application, accepting it for review one week after an initial refusal-to-file that reportedly involved senior leaders overruling staff advice.
Feb 23, 2026
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging the company's newly approved mNEXSPIKE vaccine uses proprietary mRNA technology without authorization.
Feb 19, 2026
Moderna announced the FDA will consider approving its mRNA-based flu vaccine for older adults after resolving a dispute over clinical trial design. The vaccine showed 34.5% higher efficacy than standard flu shots in trials.
Feb 17, 2026
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
Feb 18, 2026
The FDA agreed to review Moderna's mRNA-based flu vaccine after initially rejecting the application, following a Type A meeting that led to a revised regulatory approach splitting approval pathways by age group.
Feb 17, 2026
Two financial services firms raised their price targets for Moderna in mid-February 2026, with RBC Capital increasing its target to $30 and Evercore ISI Group raising its target to $35, both maintaining neutral ratings.
Feb 16, 2026
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
