Latest news with #StephaneBancel
The Hill
30-06-2025
- Health
- The Hill
Experimental Moderna flu shot more effective than approved vaccine, company says
Moderna Inc. said Monday its experimental flu shot showed positive results in a late-stage trial. In a Phase 3 study, the company's mRNA-1010 flu vaccine's efficacy was nearly 27 percent higher for adults 50 and older than a currently available shot. The shot also showed strong efficacy against each of the major influenza strains in the shot including A/H1N1, A/H3N2 and the B/Victoria lineages. Efficacy appeared consistently strong across age groups, flu vaccination status and among people with various risk factors, Moderna said in a statement. The trial enrolled more than 40,800 adults 50 and older from 11 countries. 'The severity of this past flu season underscores the need for more effective vaccines,' said Stephane Bancel, chief executive officer of Moderna. 'An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination vaccines.' Seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-25 season, according to the CDC. At least 600,000 Americans were hospitalized last year due to flu-related illness, agency data show. According to the CDC, seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. [2] More than 600,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work After consulting the Food and Drug Administration, Moderna withdrew its application last month for a dual flu and COVID-19 vaccine for adults 50 years old and older. Moderna plans to resubmit the application for the combination vaccine with the new data, according to CNBC. The company also plans to submit the data on the mRNA-1010 shot to U.S. regulators this year.
Yahoo
26-06-2025
- Business
- Yahoo
The Top 5 Analyst Questions From Moderna's Q1 Earnings Call
Moderna's first quarter results were met with a negative market reaction, as revenue fell short of Wall Street expectations and declined sharply versus the prior year. Management attributed the performance primarily to the seasonal nature of respiratory vaccine sales and lower overall COVID vaccination rates, which have become more routine rather than urgent. CEO Stephane Bancel pointed to progress in cost reduction efforts, highlighting a 19% reduction in combined cost of sales, research and development, and selling, general and administrative expenses as a sign of ongoing financial discipline. Is now the time to buy MRNA? Find out in our full research report (it's free). Revenue: $108 million vs analyst estimates of $117.9 million (35.3% year-on-year decline, 8.4% miss) Adjusted EPS: -$2.52 vs analyst estimates of -$3.11 (18.9% beat) The company reconfirmed its revenue guidance for the full year of $2 billion at the midpoint Market Capitalization: $10.39 billion While we enjoy listening to the management's commentary, our favorite part of earnings calls are the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Salveen Richter (Goldman Sachs) pressed for detail on the FDA's requirement for additional flu vaccine efficacy data and its impact on the timing for the flu/COVID combination, to which CEO Stephane Bancel explained the scientific rationale and anticipated review extension. Jasmine (UBS, for Eliana Merle) sought clarity on whether Phase 3 data for individualized neoantigen therapy (INT) remains on track for 2026, and inquired about trial expansion plans. President Stephen Hoge reiterated timelines are event-driven but remain possible, with further updates pending. Tyler Van Buren (TD Cowen) asked about the likelihood of approval for the next-generation COVID vaccine given recent regulatory leadership changes. Hoge responded that interactions with the FDA have been 'business as usual,' with no change in review process observed. Courtney Breen (Bernstein) questioned the drivers and flexibility behind the expanded cost-cutting program. CFO Jamey Mock explained that cost reductions are largely tied to the winding down of large Phase 3 trials and ongoing process improvements, rather than specific revenue signals. Gena Wang (Barclays) asked about U.S. COVID vaccine market share and future prospects, to which Mock replied that script data supports a stable market position and attributed lower reported revenue to customer inventory management rather than underlying loss of share. Looking ahead, the StockStory team will closely monitor (1) regulatory decisions for Moderna's next-generation COVID, RSV, and flu vaccines, (2) the pace and impact of ongoing cost reduction efforts as major clinical trials wind down, and (3) progress in late-stage pipeline programs—especially new data readouts for oncology and non-respiratory vaccines. Execution on product launches and continued market expansion will be key indicators of strategic progress. Moderna currently trades at $26.84, down from $28.58 just before the earnings. In the wake of this quarter, is it a buy or sell? The answer lies in our full research report (it's free). Donald Trump's victory in the 2024 U.S. Presidential Election sent major indices to all-time highs, but stocks have retraced as investors debate the health of the economy and the potential impact of tariffs. While this leaves much uncertainty around 2025, a few companies are poised for long-term gains regardless of the political or macroeconomic climate, like our Top 6 Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 183% over the last five years (as of March 31st 2025). Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today. Fehler beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten
Bloomberg
11-06-2025
- Business
- Bloomberg
Moderna Seeks Outside Investors to Fund Select Vaccine Trials
Moderna Inc. is in discussions with large drugmakers and financial firms to get funding for some late-stage vaccine trials as it works to develop its product portfolio while cutting costs. 'We are very actively talking to potential partners right now,' Chief Executive Officer Stephane Bancel said Wednesday at the Goldman Sachs Annual Global Healthcare Conference. The discussions are with pharmaceutical companies and other types of financial partners, he said.
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First Post
03-06-2025
- Health
- First Post
US okays Moderna's 'next generation' Covid-19 vaccine
The new vaccine, mNexspike (mRNA-1283), is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose, a fifth of the dose of its current COVID-19 vaccine, Spikevax (mRNA-1273) by refining its immune target read more Moderna logo is seen displayed in this illustration taken, May 3, 2022. REUTERS Moderna, a vaccine manufacturer, said late last week that the FDA has authorised its next-generation COVID-19 vaccine. The new vaccine, mNexspike (mRNA-1283), is a step toward next-generation coronavirus vaccines. It's made in a way that allows for a lower dose, a fifth of the dose of its current COVID-19 vaccine, Spikevax (mRNA-1273) by refining its immune target. Moderna's approval was based on a phase 3 randomised controlled trial involving 11,400 participants ages 12 and older. The trial found that a 10-microgram (μg) dose of mNexspike demonstrated a 9.3% higher relative vaccine efficacy (rVE) compared to a 50-μg dose of Spikevax, with a 13.5% higher rVE in adults ages 65 and older. The two vaccinations have identical safety profiles, according to the manufacturer. STORY CONTINUES BELOW THIS AD The approval 'adds an important new tool to help protect people at high risk of severe disease from COVID-19,' Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus. That's the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax. Those restrictions are a departure from how the US has handled COVID-19 vaccines until now, reflecting scepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. Moderna's existing vaccine doesn't face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall. The news came just days after the Trump administration cancelled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results. STORY CONTINUES BELOW THIS AD
Reuters
02-06-2025
- Business
- Reuters
US FDA approves Moderna's next-generation COVID vaccine for adults 65 or older
May 31 (Reuters) - The U.S. Food and Drug Administration has approved Moderna's (MRNA.O), opens new tab next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention, Moderna said in a statement. The company said it expects to have the vaccine, called mNEXSPIKE, available for the 2025-2026 respiratory virus season. "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," CEO Stephane Bancel said in the statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines. The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule. The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots. FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots. Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine. The approval for mNEXSPIKE was based on late-stage trial data, which showed the shot was not inferior in efficacy compared to Spikevax in individuals aged 12 years and older. The shot also showed superior efficacy compared to Spikevax in adults 18 years of age and older in the study. Kennedy has kickstarted a major overhaul of health departments, laying off thousands of employees to align with President Donald Trump's goal of dramatically shrinking the federal government. This has further ignited worries about potential disruptions to the regulatory review of treatments and vaccines. The CDC's outside panel of vaccine experts in April discussed recommending the booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign. The FDA approved Novavax's COVID vaccine Nuvaxovid this month, limiting its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness. Conditions that constitute additional risk range from illnesses such as diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC. While Moderna's shots, as well as Pfizer-BioNTech's Comirnaty, are mRNA-based, Novavax's vaccine is protein-based and takes longer to manufacture. Moderna this month withdrew an application seeking approval for its flu-and-COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot.
