Key Takeaways Moderna gained full FDA approval for Spikevax in high-risk children aged six months to 11 years. The vaccine was previously available for this group only under Emergency Use Authorization. Updated Spikevax will be available for eligible patients in the 2025-2026 U.S. vaccination season.Moderna (MRNA) announced that the FDA has approved its supplemental biologics license application seeking approval for COVID-19 vaccine, Spikevax, for use in children aged six months to 11 years, who are at in ...

Group 1: Moderna's Vaccine Approval - The U.S. FDA has approved Moderna's supplemental Biologics License Application for Spikevax, allowing its COVID-19 vaccine for children aged six months to 11 years at increased risk for COVID-19 disease [1] - Moderna's CEO emphasized the importance of vaccination for protecting children against severe disease and hospitalization, expressing appreciation for the FDA's review and approval [2] - The updated Spikevax vaccine is expected to be available for eligible populations in the U.S. for the 2025-2026 respiratory virus season [2] Group 2: Legal Challenges and Patent Issues - Pfizer and BioNTech have requested a reversal of a court ruling that found their COVID-19 vaccine infringed on a Moderna patent, while a previous ruling declared one of Moderna's patents invalid [3] - The companies argue that Moderna's mRNA technology is a continuation of earlier research, questioning the validity of the patent [4] - Moderna maintains that the court's decision to uphold the patent is correct and should remain [4] Group 3: FDA's Vaccine Approval Decisions - The FDA's top vaccine official overruled agency scientists to limit the approval of two COVID-19 vaccines, despite recommendations for broader use [6] - The official restricted the vaccines to higher-risk individuals, citing declining hospitalization and death rates from COVID-19 as a factor in the decision [7] - Following the news, Moderna's stock price increased by 3.60% to $33.97 [7]

Core Viewpoint - Moderna has experienced a significant increase in stock value, gaining over 12% recently, driven by positive developments in its vaccine research [1]. Group 1: Vaccine Development - Moderna published results from a late-stage study of its seasonal flu vaccine, mRNA-1010, which demonstrated a stronger immune response compared to standard flu vaccines [2]. - The company plans to resubmit its application for a combination COVID-19/flu vaccine, following the withdrawal of its previous application in May [4]. - CEO Stéphane Bancel highlighted the trial results as a significant milestone in reducing influenza burden in older adults [5]. Group 2: Market Sentiment - Despite the positive news regarding the flu vaccine, there is skepticism about whether this development alone will make Moderna's stock a compelling buy [5]. - The company has a robust pipeline of development programs, which could enhance the attractiveness of its shares if any show promise [6].

Key Takeaways Moderna received FDA approval for mNexspike, its next-gen COVID-19 vaccine with limited use criteria. Vaccine is cleared for older adults and high-risk individuals aged 12-64, not the broader group MRNA wanted. The vaccine offers a better shelf life and matched or outperformed Spikevax in late-stage trial data.Moderna (MRNA) announced the FDA approval for mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, though for a label narrower than initially targeted. The vaccine will ...

Moderna (MRNA) announced that it has submitted a regulatory filing with the FDA seeking approval for an updated version of its COVID-19 vaccine Spikevax, designed to target the LP.8.1 variant of the virus.The submission is based on guidance from the FDA issued last week, which advised vaccine-makers to update their COVID-19 shots to target strains that are part of the JN.1 lineage, with a preference for the LP.8.1 variant. Per the latest CDC data, LP.8.1 currently accounts for about 70% of total cases in th ...

Moderna (MRNA) kicked off 2025 with mixed first-quarter results. While its streamlining efforts improved bottom-line numbers, the steep decline in revenues raises concerns.While sales of its COVID-19 vaccine continue to decline as expected in a post-pandemic market, Moderna is taking proactive steps to reshape its future. The company is swiftly advancing multiple pipeline candidates across late-stage development, with the intent to diversify its existing revenue base and launch multiple new products over th ...

Moderna Inc. MRNA reported on Thursday a first-quarter EPS loss of $(2.52), missing the consensus of $(3.12), down from an EPS loss of $(3.07) a year ago.The COVID-19 vaccine maker reported quarterly sales of $108 million, down from $167 billion a year ago, beating the consensus of $106.20 million.The decline was primarily driven by lower net product sales, which totaled $86 million in the quarter.The reduction in product sales reflects lower vaccination rates compared to the same period last year and the c ...

Moderna (MRNA) incurred a loss of $2.52 per share in the first quarter of 2025, narrower than the Zacks Consensus Estimate of a loss of $2.92. In the year-ago period, the company had reported a loss of $3.07.Total revenues in the quarter were $108 million, which missed the Zacks Consensus Estimate of $127 million. Revenues declined around 35% year over year, owing to lower net product sales. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)More on MRNA’s Q1 EarningsModerna currently ...

© 2025 Moderna, Inc. All rights reserved. Forward-looking statements and disclaimer First Quarter 2025 Financial Results May 1, 2025 This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: Moderna's ability to drive use of Spikevax and mRESVIA and expand markets for its products; Moderna's 2025 financial framework; Moderna's ability to deliver cost efficiency across the business, including a ...

In many ways, the pandemic is becoming a faded memory. With that, a major pandemic star -- biotech Moderna (MRNA -0.79%) -- also seems to be disappearing from the world's attention. The company's stock is down a headache-inducing 36% year to date, compared to the S&P 500 index's mere 9% slide. This doesn't mean Moderna is inactive; in fact, it's quite the opposite. Let's see if that, combined with its considerable price weakness, makes it something of a stealth buy today. The two first-mover vaccines both s ...