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.
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.
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.
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.
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.
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.
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.
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.
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.
