Latest news with #mResvia
Yahoo
3 days ago
- Health
- Yahoo
MRNA Stock Jumps on CDC's Revised RSV Vaccine Recommendations
Shares of Moderna MRNA rose nearly 6% yesterday after the U.S. Centers for Disease Control and Prevention ('CDC') adopted new recommendations for the use of RSV vaccines in the upcoming respiratory virus season. The revised recommendations lower the recommended age for RSV vaccination. Now, adults aged 50-59 who are at higher risk of severe illness from the disease are advised to receive a single dose of the vaccine. The previous CDC guidance recommended RSV vaccines for people aged 75 and older, as well as those aged between 60-74 who were at high risk of the disease. Per the CDC's website, this recommendation was officially adopted last week by the current HHS secretary, Robert F. Kennedy, Jr. Although the CDC director typically accepts or rejects such recommendations, the position is currently vacant, so Kennedy fulfilled that role. President Trump has backed Susan Monarez as his nominee for the post, but her appointment is still pending confirmation by the U.S. Senate. The broader recommendations come as a surprise because the members of the CDC's advisory committee — who initially made the recommendation earlier this year — were all removed by RFK Jr. last month. Year to date, the stock has lost 27% compared with the industry's 2% decline. Image Source: Zacks Investment Research The expanded CDC recommendations widen Moderna's addressable market for its RSV vaccine, mResvia. By lowering the recommended age group, the guidance opens up a new segment of eligible patients who were previously excluded. Moderna is one of a handful of companies marketing an RSV vaccine. Though mResvia was initially approved last year for use in people aged 60 and older, the FDA expanded its label last month to include high-risk individuals aged between 18-59. Despite commercially launching the vaccine last year, mResvia sales were modest as it was approved and recommended later in the contracting season. By that point, many people had already completed their vaccinations with either GSK's GSK Arexvy or Pfizer's PFE Abrysvo. RSV vaccines gained traction in 2023 with the initial approvals of Arexvy and Abrysvo — the first FDA-approved RSV vaccines. At the time, the CDC issued blanket approvals for use among individuals aged 60 and older. However, the CDC later narrowed that guidance, which trimmed the target market last year. That, combined with the earlier availability of GSK and Pfizer's offerings, gave both companies a dominant position over Moderna. Both GSK and Pfizer vaccines are already approved for use in individuals aged 60 and older. While GSK's Arexvy is approved for use in high-risk individuals aged 50-59, PFE's Abrysvo is approved for use in high-risk people aged 18-59. The Pfizer vaccine is also approved for use in infants through maternal immunization. Moderna, Inc. price | Moderna, Inc. Quote Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Moderna, Inc. (MRNA) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research


Globe and Mail
3 days ago
- Health
- Globe and Mail
MRNA Stock Jumps on CDC's Revised RSV Vaccine Recommendations
Shares of Moderna MRNA rose nearly 6% yesterday after the U.S. Centers for Disease Control and Prevention ('CDC') adopted new recommendations for the use of RSV vaccines in the upcoming respiratory virus season. The revised recommendations lower the recommended age for RSV vaccination. Now, adults aged 50-59 who are at higher risk of severe illness from the disease are advised to receive a single dose of the vaccine. The previous CDC guidance recommended RSV vaccines for people aged 75 and older, as well as those aged between 60-74 who were at high risk of the disease. Per the CDC's website, this recommendation was officially adopted last week by the current HHS secretary, Robert F. Kennedy, Jr. Although the CDC director typically accepts or rejects such recommendations, the position is currently vacant, so Kennedy fulfilled that role. President Trump has backed Susan Monarez as his nominee for the post, but her appointment is still pending confirmation by the U.S. Senate. The broader recommendations come as a surprise because the members of the CDC's advisory committee — who initially made the recommendation earlier this year — were all removed by RFK Jr. last month. MRNA Stock Price Performance Year to date, the stock has lost 27% compared with the industry 's 2% decline. How Does the Revised CDC Guidance Benefit Moderna? The expanded CDC recommendations widen Moderna's addressable market for its RSV vaccine, mResvia. By lowering the recommended age group, the guidance opens up a new segment of eligible patients who were previously excluded. Moderna is one of a handful of companies marketing an RSV vaccine. Though mResvia was initially approved last year for use in people aged 60 and older, the FDA expanded its label last month to include high-risk individuals aged between 18-59. Despite commercially launching the vaccine last year, mResvia sales were modest as it was approved and recommended later in the contracting season. By that point, many people had already completed their vaccinations with either GSK 's GSK Arexvy or Pfizer 's PFE Abrysvo. RSV vaccines gained traction in 2023 with the initial approvals of Arexvy and Abrysvo — the first FDA-approved RSV vaccines. At the time, the CDC issued blanket approvals for use among individuals aged 60 and older. However, the CDC later narrowed that guidance, which trimmed the target market last year. That, combined with the earlier availability of GSK and Pfizer's offerings, gave both companies a dominant position over Moderna. Both GSK and Pfizer vaccines are already approved for use in individuals aged 60 and older. While GSK's Arexvy is approved for use in high-risk individuals aged 50-59, PFE's Abrysvo is approved for use in high-risk people aged 18-59. The Pfizer vaccine is also approved for use in infants through maternal immunization. MRNA's Zacks Rank Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in the coming year. While not all picks can be winners, previous recommendations have soared +112%, +171%, +209% and +232%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >> Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report GSK PLC Sponsored ADR (GSK): Free Stock Analysis Report Pfizer Inc. (PFE): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report This article originally published on Zacks Investment Research (
Yahoo
13-06-2025
- Health
- Yahoo
Moderna wins FDA OK to widen use of RSV vaccine
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The Food and Drug Administration has approved wider use of Moderna's respiratory syncytial virus vaccine in a boost for a company that's been negatively impacted by the recent leadership changes atop U.S. public health agencies. The shot, dubbed mResvia, was cleared on Thursday for adults aged 18 to 59 who are at high risk for increased risk of RSV-related disease. Prior to the label expansion, Moderna's shot was only available to adults 60 or older. "RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," Moderna CEO Stéphane Bancel said in a statement. The expansion is a much-needed win for Moderna, which has been among those hardest hit by the changes in vaccine policy enacted by new FDA leaders Martin Makary and Vinay Prasad, as well as Health and Human Services Secretary Robert F. Kennedy Jr. Makary and Prasad, for instance, have outlined stricter approval standards for COVID-19 vaccines and called for developers to perform more placebo-controlled trials. Kennedy Jr., who has long been critical of the kind of messenger RNA vaccines Moderna is known for, has said the Centers for Disease Control and Prevention would remove COVID shots from the recommended immunization schedules for pregnant women and healthy children. He also, this week, overhauled the CDC panel that determines who should get which vaccines and shapes private insurance coverage for inoculations. Some of the new members of the eight-person panel include vaccine skeptics and doctors with different focus areas. The changes at the CDC could have important implications for Moderna. In April, the CDC panel recommended broadening use of RSV shots to enable adults 50 to 59 years of age who are at a higher risk of severe RSV-related disease to get vaccinated. But the agency still doesn't have an acting director, and Kennedy Jr. has yet to endorse that recommendation. Without a formal clearance, insurers are not required to cover the cost of the shot. The newly constituted panel's first meeting is scheduled for June 25-27, and will be closely watched by investors. In a research note Friday, William Blair analyst Myles Minter noted that the gathering will be 'important for sentiment in the vaccine sector, which continues to decline.' Minter believes Moderna, which has seen its share price plummet more than 80% over the last year, will need to significantly cut costs to meet its objective of breaking even financially by 2028.
Yahoo
16-05-2025
- Business
- Yahoo
1 Beaten-Down Stock to Buy Right Now, and 1 to Avoid
Moderna's clinical progress and deep pipeline of mRNA candidates suggest a promising future. Teladoc continues to lose market share in the competitive telehealth space -- a serious concern. 10 stocks we like better than Moderna › Equity markets are full of bargains -- stocks that have performed terribly in recent months, whether due to trade-related marketwide issues or company-specific troubles, but could bounce back once things improve. There are also companies that are not performing well and are unlikely to rebound anytime soon; that's the kind investors should stay away from. Let's consider one stock in each category: Moderna (NASDAQ: MRNA), a beaten-down stock with decent prospects, and Teladoc Health (NYSE: TDOC), one whose future looks dim. Until about five years ago, mRNA vaccines were just a promising idea. Thanks to the success of COVID-19 vaccines, one of which was developed and marketed by Moderna, the mRNA field has proven it can deliver. That's what makes Moderna's prospects attractive. The company's shares have lagged the market over the past three years since it no longer generates the kinds of earnings it did in the early pandemic days. However, Moderna has made significant clinical progress since. A year ago it earned approval for mResvia, a respiratory syncytial virus vaccine. Moderna also has a deep pipeline of potential products, and could see its portfolio of approved vaccines transformed in the next five years. Among the more promising is mRNA-4157, a potential personalized cancer vaccine. This product showed strong results in phase 2 studies: It reduced the risk of recurrence and death in melanoma patients in combination with Merck's cancer drug Keytruda, compared to Keytruda alone. It's now undergoing a phase 3 study in melanoma. Moderna is also targeting other forms of cancer with mRNA-4157 -- the drug is being investigated in no fewer than six phase 2 or phase 3 studies. Moderna also has a promising stand-alone influenza vaccine and a combined COVID/flu shot that are both inching closer to approval. The biotech should remain a leader in the COVID vaccine market. Its $2 billion revenue guidance (at the midpoint) largely reflects its work in this field. Moderna is also working on cost-cutting efforts; it plans to reduce between $1.4 billion and $1.7 billion in operating expenses by 2027. By then, the company should have at least one other growth driver in its lineup, and possibly several. With stronger revenue, lower costs, and a pipeline of mRNA vaccines that are faster to develop than traditional ones, Moderna could go on to perform well and deliver excellent returns. The stock might be down substantially over the past three years, but it isn't out of the picture yet. Teladoc Health is a telemedicine specialist that rose in popularity in 2020 and 2021, when people were stuck at home and forced to turn to telehealth for medical attention. Though virtual care hasn't disappeared since then, Teladoc isn't performing as well as it once was. The company's revenue growth has slowed to a near halt. It also remains unprofitable, despite strong gross margins in the neighborhood of 70%. That was on display again in the first quarter. Revenue for the period was down 3% year over year to $629.4 million, while the net loss per share was $0.53, worse than the $0.49 reported in the year-ago period. In fairness to Teladoc, this net loss included a non-cash goodwill impairment charge related to a recent acquisition. Still, the company has had similar charges that led to catastrophic bottom-line numbers more than once in the past few years. An isolated event might not be a big deal, but it no longer feels that way with Teladoc. Furthermore, total visits declined compared to the first quarter of 2024. The company has faced several headwinds, including a ruthless competitive landscape. Its therapy service, BetterHelp, is a good example. Though it was once Teladoc's biggest growth driver, BetterHelp has been losing members. In the first quarter, subscribers declined by 4% year over year to 397,000. Teladoc Health has various ideas to turn things around, including investing in its international expansion plans. But if it couldn't dominate the market in the U.S., can it do so elsewhere? In my view, the stock looks too risky for investors to jump in right now. Teladoc may one day once again crack the code to success. Until then, it's best to watch from the sidelines. Before you buy stock in Moderna, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Moderna wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $620,719!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $829,511!* Now, it's worth noting Stock Advisor's total average return is 959% — a market-crushing outperformance compared to 170% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 12, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Merck and Teladoc Health. The Motley Fool recommends Moderna. The Motley Fool has a disclosure policy. 1 Beaten-Down Stock to Buy Right Now, and 1 to Avoid was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data