All articles tagged with #moderna
Topline results from a large trial show Moderna and Merck’s cancer vaccine, intismeran autogene, reduced recurrence or spread of surgically removed melanoma, signaling a milestone after years of doubt and pandemic-related hurdles—though some scientists urge waiting for fuller data and longer follow-up before declaring a definitive breakthrough.
The FDA approved Moderna’s mFLUSIVA (mRNA-1010), the first mRNA-based seasonal flu vaccine, for adults 50 and older, based on phase 3 data showing superior protection against flu-like illness versus standard vaccines; accelerated approval for 65+, with post‑approval confirmatory data required. The vaccine can be produced more quickly to better match evolving influenza strains, potentially adding an important option without replacing existing vaccines; common vaccine side effects apply, and availability is anticipated for the 2026–2027 season.
Quant hedge funds had their worst day in over two years as the U.S. Treasury moved to double long‑term debt purchases to shore up the bond market, adding pressure to momentum strategies already shaken by an AI stock sell‑off. Goldman Sachs said its global momentum index was well outside historical norms, with systematic long‑short funds down about 1.4% at 1pm ET, and Morgan Stanley’s pure momentum index dropping more than 4% while the S&P 500 rose. Moderna surged nearly threefold after positive trial results for an experimental skin‑cancer therapy, underscoring the day’s dramatic stock moves. Despite the setback, systematic long‑short funds were up about 1.7% for the month, and traders warn that volatility remains extreme, noting notable losses at Jane Street and the Situational Awareness fund as risk-off sentiment broadens.
Moderna’s personalized cancer vaccine mRNA-4157 (intismeran autogene) paired with Merck’s Keytruda hit key Phase 3 melanoma endpoints, delivering a 49% reduction in recurrence or death versus Keytruda alone and sparking a 177% one‑day stock surge before shares retraced about 20% as investors took profits; Moderna’s pipeline spans nine Phase 2/3 studies across melanoma, NSCLC, bladder and kidney cancers, despite a $950 million settlement and a norovirus program setback, while Merck’s KEYTRUDA franchise remains a critical driver for oncology growth.
Moderna's stock surged about 177% after news that its personalized mRNA cancer vaccine intismeran, in combination with Merck's Keytruda, reduced melanoma recurrence in a Phase 3 trial, signaling a potential shift for the biotech beyond infectious disease. Analysts from Jefferies, Bank of America, Citi, and JPMorgan call the result a watershed for Moderna's oncology outlook, with upside if label expansions and cross-indication uptake materialize, though questions remain about dataset completeness and commercial adoption. Fuller data and presentations are expected at the upcoming ESMO meeting, while the stock cooled slightly in premarket trading after yesterday's rally.
Moderna’s personalized mRNA cancer vaccine Intismeran Autogene, developed with Merck, showed Phase 3 melanoma trial success when paired with Keytruda, triggering a roughly 176% stock rally and making Moderna the S&P 500’s second-best performer this year as analysts boost bets on its cancer pipeline, though the magnitude of benefit and potential launches remain under review.
Moderna and Merck reported that their experimental mRNA cancer vaccine, intismeran, when combined with Merck’s Keytruda, produced a clinically meaningful improvement in high-risk melanoma across more than 1,100 patients, with safety consistent with prior studies; the trial could pave the way for a commercial launch next year and signals potential for an expanded mRNA cancer platform, triggering a sharp rally in Moderna’s stock and a solid gain for Merck.
Broadcom fell about 4.7%, dragging the Nasdaq lower early in the session due to its index-heavy weight, while the Dow and S&P 500 advanced on gains in Moderna and Merck and a favorable rotation in tech led by Marvell’s deal with Google. Oil and Treasury yields rose, and safe-haven assets gold and Bitcoin also moved higher, signaling a mixed risk backdrop as the broader market climbed despite the Nasdaq’s weakness.
Merck and Moderna reported positive phase 3 results for a personalized mRNA cancer vaccine used with Keytruda in melanoma patients who had surgery, significantly extending disease-free survival and reducing the risk of distant metastasis versus Keytruda alone; safety was comparable to vaccines, and the teams will pursue regulatory submissions while continuing to assess overall survival.
FDA approves Moderna’s mRNA-based flu vaccine, mFlusiva, for adults 50 and older (standard approval for ages 50–64 and accelerated approval for 65+), leveraging faster manufacturing to allow strain updates closer to the season. In a large trial, it was about 27% more effective than standard flu shots in people over 50 but had more mild to moderate side effects; serious events were similar to other vaccines. A post-marketing study is required, and availability may be limited this fall while a CDC recommendation is pending due to a delay in the ACIP meeting. Insurance coverage remains uncertain until guidelines are issued. The vaccine could be a valuable option for an older population at higher risk of severe flu outcomes.
FDA approves Moderna’s mFlusiva, the first mRNA-based flu vaccine, for adults 50+, with standard approval for 50–64 and accelerated approval for 65+, enabling faster production and closer strain matching; in a 40,000+ participant trial it was about 27% more effective than standard vaccines for ages 50+, though with more transient side effects; a post-marketing study is required, rollout may be limited this fall, and insurance coverage remains unclear until ACIP weighs in (scheduled for October).
The FDA approved Moderna’s mRNA flu vaccine, mFLUSIVA, for adults 50–64 and gave accelerated approval for adults 65+, with the potential to rapidly reformulate to match circulating influenza strains. In trials, it showed a 26.6% relative reduction in lab-confirmed flu versus standard vaccines and was generally well tolerated, though side effects were more common. Regulators in the EU, Canada, and Australia are reviewing similar uses, and a Phase IV trial is planned to assess efficacy against an enhanced 65+ vaccine. Separately, Europe has approved a combined influenza and COVID-19 mRNA vaccine (mCombriax). Experts say the technology could improve responsiveness to evolving flu strains and ease manufacturing bottlenecks, but real-world effectiveness will determine its ultimate impact.
FDA-approved Moderna’s mFlusiva, an mRNA flu vaccine, for adults 50–64 (full approval) and 65+ (accelerated approval) after trials showed about 27% higher effectiveness than the standard flu shot; the vaccine could be updated quickly to address circulating strains. It’s expected to be available this fall, though insurance coverage remains unclear. Side effects may be stronger than with traditional vaccines but are generally mild. Health experts say to get whichever flu vaccine is available to protect yourself early in the season.
Regulators approved Moderna’s mFlusiva, a new mRNA flu vaccine, for adults 50 to 64 (fully) and 65+ (accelerated) after trials showed about 27% greater effectiveness than standard flu shots; the vaccine, available this fall, uses mRNA technology to allow faster production and potential yearly updates to match circulating strains, though side effects may be stronger than traditional vaccines; if you’re eligible, get whichever flu shot is available to start protection early in the season.
The FDA has approved Moderna’s mFlusiva as the United States' first mRNA flu vaccine, giving adults 50+ access with full approval for ages 50–64 and accelerated approval for 65+, following a trial that showed it outperformed a standard-dose flu vaccine and suggesting mRNA could speed vaccine updates to evolving flu strains and potentially improve seasonal vaccines.