All articles tagged with #moderna
Moderna co-founder Kenneth Chien remains bullish on mRNA’s potential, predicting an mRNA cancer vaccine could reshape oncology and lift the entire field, even as past Moderna–AstraZeneca deals failed to deliver the planned drugs.
Moderna disclosed its first in vivo CAR-T program, mRNA-6007, which uses a lipid nanoparticle to deliver CAR-T mRNA to CD4/CD8 T and NK cells to target and deplete pathogenic B cells in autoimmune diseases. Marketed as an off-the-shelf approach, it aims to simplify manufacturing and expand access versus traditional ex vivo CAR-T. The therapy is in early IND-enabling stages and is slated to enter the clinic next year, with lupus and other B-cell–mediated conditions among the initial targets; if successful, it could enable larger-scale development, including future oncology applications.
An FDA advisory panel unanimously recommended approving Moderna’s mFlusiva, the first influenza vaccine made with mRNA technology, for adults ages 50–64 and 65+ pending final FDA clearance by early August. The shot could enable faster manufacturing and better matching to circulating strains. In trials, it reduced flu cases by about 27% in people 50+ versus a standard vaccine and produced a strong immune response in 65+ compared with a high-dose vaccine, with mostly mild, temporary reactions. If approved, Moderna will run a large follow-up study (about 400,000 people 65+) over two seasons to gather more safety and efficacy data, including in frail or immunocompromised individuals.
An FDA advisory panel unanimously recommended Moderna’s mRNA flu vaccine (mFlusiva) for adults 50 and older, approving it for two age groups (50–64 and 65+), with a requirement for an additional post‑market trial in the older cohort. In trials, the shot was about 27% more effective than standard flu vaccines. If FDA and then CDC sign off, it could become the first mRNA influenza vaccine, and its flexible, quickly updated design could help match circulating strains, though final timelines and access this fall remain uncertain amid regulatory and political considerations.
FDA advisors voted 9-0 to approve Moderna’s mRNA-1010 seasonal flu vaccine (mFlusiva) after a Trump-era official briefly blocked review; Phase 3 data show ~27% higher efficacy than standard flu vaccines in adults 50+, with strong immune responses in older adults and a generally favorable safety profile. A final FDA decision is due by August 5, and CDC/ACIP recommendations would follow for coverage, though ACIP is currently affected by an injunction tied to vaccine-administration policy.
An FDA advisory panel is evaluating Moderna’s experimental mRNA-based influenza vaccine, a first-of-its-kind flu shot, with safety and efficacy data under review to determine if it could join future vaccination programs.
CEPI pledged over $60 million to accelerate Bundibugyo ebolavirus vaccine development, including up to $50 million to Moderna for preclinical work and early-stage trials of an mRNA BDBV vaccine and to ramp up manufacturing for larger Phase 2/3 testing; other funds go to IAVI and the Oxford/Serum Institute effort. No licensed vaccines exist for Bundibugyo yet, and the current DRC outbreak has about 1,041 cases and 241 deaths as reported by the WHO.
Moderna and Korea University’s Vaccine Innovation Center have been collaborating since 2023 to create an mRNA hantavirus vaccine; early preclinical results in mice (reported in 2025) show protection, but the vaccine is not yet in humans and faces funding, regulatory, and multi-strain coverage challenges, as there is currently no licensed hantavirus vaccine and the effort aims for a broad-spectrum solution in line with pandemic‑preparedness goals.
Biotech stocks such as Moderna, Inovio, and Novavax rose on hantavirus outbreak headlines, but analysts cautioned the moves are sentiment-driven with limited revenue potential; Moderna noted ongoing preclinical hantavirus work with USAMRIID, while the WHO said the public health risk remains low and the incident appears contained.
Moderna says it’s pursuing early-stage hantavirus vaccine work with the US Army Medical Research Institute of Infectious Diseases and Korea University’s Vaccine Innovation Center, begun before the Hondius cruise-ship outbreak, as public health officials say the immediate risk remains limited while the company develops countermeasures.
Moderna’s shares jumped about 14% after news of early hantavirus vaccine research with the U.S. Army and Korea University, though executives say the work is in its infancy and not close to a vaccine. Experts note funding has been limited because hantavirus outbreaks are rare, suggesting a vaccine could be years or even a decade away. Wall Street shows a Hold consensus on MRNA with a $41.75 target implying potential downside, so the stock move reflects long‑term research interest rather than near‑term product prospects.
Moderna, Inc. stock rose about 12% on news of a hantavirus outbreak, signaling investor optimism for potential vaccine demand; the move pushed Moderna’s share price toward the low $50s, reflecting broader market enthusiasm for vaccine developers amid outbreak concerns.
In a Phase 3 trial of more than 40,000 adults aged 50+, Moderna's mRNA influenza vaccine reduced illness to about 2.0% vs 2.8% for standard vaccines (roughly 27% more effective), with similar improvement in adults 65+. Side effects were mild. The FDA decision on licensure is expected by Aug. 5, as Moderna pursues approval; no mRNA flu vaccine is approved anywhere yet.
Bank of America’s latest data rank the 20 stocks hedge funds are most shorted; Moderna (MRNA) leads with about 18.3% of its float short, followed by names like SMCI, CHTR, APA, HPQ, BBY, WDC and MGM, illustrating broad bets against a wide mix of equities as the S&P 500 sits roughly 3% lower year-to-date.
FDA vaccine chief Dr. Vinay Prasad is leaving the agency at the end of April to return to UCSF, marking a second departure in under a year amid ongoing controversies over vaccine and rare-disease drug reviews, including disputes with Moderna over an mRNA flu vaccine and with UniQure on a Huntington's disease gene therapy.