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]

Financial Status and Strategy - CureVac has a strong financial position with €550.9 million in cash as of September 30, 2024, and an expected cash runway into 2028[82, 87] - The company streamlined costs and enhanced financial discipline, including a 30% workforce reduction expected by the end of 2024[8, 85, 88] - CureVac refocused its portfolio on innovation and R&D, concentrating on high-value programs in infectious diseases and oncology[8, 9] - A strategic transformation is on track, with OPEX expected to decrease by over 30% from 2025 onwards, including a €25 million decrease in personnel costs[85] Pipeline and Development - CureVac is advancing key pipeline milestones for novel medicines targeting unmet needs, with a focus on expanding the pipeline in oncology and infectious diseases[10, 14] - In oncology, a new shared-antigen lung cancer program is set to start clinical trials in H2 2025, and personalized cancer vaccines are progressing with the first candidate expected to enter the clinic in H2 2026[14] - For infectious diseases, a new non-respiratory program was initiated for Uropathogenic E coli (UPEC) in urinary tract infections, with promising preclinical data[14] - Respiratory infectious disease programs, including seasonal influenza, avian influenza, and COVID-19, are fully out-licensed to GSK, with Phase 3 starting for seasonal flu in 2025[13, 37, 86] Technology and Manufacturing - CureVac's mRNA platform is versatile, featuring precision mRNA backbone, improved LNP delivery systems, and a strong intellectual property portfolio[12, 13] - The company utilizes advanced delivery systems, including proprietary therapeutic area-specific next-generation lipid nanoparticles, and scalable manufacturing, including The RNA Printer®[12] - CureVac's Infectious Disease LNP offers thermostability for more than 12 months at refrigerator temperature (2-8°C)[60]

Summary of Moderna (MRNA) Update / Briefing June 16, 2025 Company Overview - **Company**: Moderna (MRNA) - **Focus**: Oncology pipeline and commercial strategy Key Points on Oncology Pipeline 1. **Oncology as a Key Focus**: The company emphasizes the importance of oncology in its future development, with a focus on individualized therapies and cancer antigen therapies [3][4] 2. **Lead Program - Intisiran Auto Gene (INT)**: This individualized neoantigen therapy has shown a 49% reduction in the risk of recurrence or death in a Phase 2 study for adjuvant melanoma, with pivotal study data expected in 2026 [7][39] 3. **Expansion of INT**: The company is exploring INT in various cancer settings, including combinations with pembrolizumab and as a monotherapy [7][8] 4. **Off-the-Shelf Cancer Antigen Therapies**: These therapies are designed for broader patient use and are currently in development, with lead programs mRNA-4106 and mRNA-4359 targeting specific tumor antigens and training the immune system [10][11] 5. **T Cell Engagers**: The company is developing multiplexed T cell engagers that can target multiple proteins on cancer cells, enhancing the immune response [16][17] 6. **In Vivo Cell Therapies**: Moderna is pursuing innovative approaches to enhance the efficacy of cell therapies, including engineered T cells that can be modified within the patient's body [20][24] Clinical Development and Data 1. **Phase 2 and Phase 3 Studies**: The company is preparing for Phase 3 trials based on encouraging Phase 2 data, with a focus on event-driven trial designs [34][40] 2. **Control Arm Performance**: The performance of the pembrolizumab control arm in Phase 2 is reported to be in line with historical data, addressing investor concerns about patient allocation [32][36] 3. **Safety and Tolerability**: The safety profile of mRNA-4359 and INT is favorable, with low-grade adverse events and no dose-limiting toxicities reported [15][62] Market and Competitive Landscape 1. **Partnerships and Collaborations**: Moderna is closely monitoring competitive developments, including BioNTech's recent acquisition of CareVac and their oncology programs [78] 2. **Regulatory Environment**: The company is navigating a changing political landscape that affects vaccine development and approval processes, particularly in the context of COVID-19 and RSV vaccines [82][86] Financial Guidance and Market Outlook 1. **Revenue Guidance**: Moderna has provided a broad revenue guidance range of $1.5 billion to $2.5 billion for the year, considering potential declines in vaccination rates and other market factors [96] 2. **Future Approvals**: The company is optimistic about upcoming FDA approvals and the potential for expanded indications for its vaccines, particularly for high-risk populations [85][89] Additional Insights 1. **Combination Therapies**: The company is exploring combination therapies with checkpoint inhibitors and other agents, aiming to enhance overall response rates and progression-free survival (PFS) [65][66] 2. **Clinical Trial Design**: The design of clinical trials is being carefully considered, with a focus on achieving statistically significant outcomes that can support regulatory filings [50][52] This summary captures the essential points discussed during the call, highlighting Moderna's strategic focus on oncology, clinical development progress, market positioning, and financial outlook.

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced and qualified news journalists who produce independent content [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The news team delivers insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

After soaring to success in the early days of the COVID-19 pandemic, Moderna (MRNA 0.20%) experienced a reversal of fortune. The coronavirus vaccine maker has seen revenue plummet as demand for this flagship product -- Moderna's first to be approved -- has slipped. As a result, the stock fell out of favor with investors, leading to a decline of about 80% over the past three years.Since that time, the biotech company has delivered positive news, from the approval of a second product -- its respiratory syncyt ...

Moderna, Inc. (NASDAQ:MRNA) Goldman Sachs 46th Annual Global Healthcare Conference June 11, 2025 8:40 AM ET Company Participants Stéphane Bancel - CEO & Director Conference Call Participants Salveen Jaswal Richter - Goldman Sachs Group, Inc., Research Division Salveen Jaswal Richter Great. Good morning, everyone. Thank you so much for joining us. Really pleased to have Stéphane Bancel, CEO of Moderna, with us. Question-and-Answer Session Salveen Jaswal Richter Maybe to start here, Stéphane, in the context o ...

Company Overview - Moderna is focused on building a diverse portfolio of products utilizing mRNA technology, targeting areas such as infectious diseases, cancer, rare diseases, and autoimmune diseases [3]. Strategic Priorities - The company has outlined three main priorities for the year: 1. To drive sales through approved products, specifically COVID-19 and RSV vaccines [3]. 2. To launch new products to diversify and grow the top line, with up to 10 launches planned over the next few years and several Biologics License Applications (BLAs) already filed [4]. 3. To resize the company from a cost perspective in response to the transition from pandemic-related sales [4].

Moderna TodayMRNAModerna$25.80 -2.19 (-7.82%) 52-Week Range$23.15▼$170.47Price Target$53.95Add to WatchlistModerna Inc. NASDAQ: MRNA is down 35% in 2025, making it one of the worst-performing stocks among medical stocks and the broader market. Not surprisingly, the stock is down over 80% in the last 12 months. What may surprise investors is that the Moderna stock is down approximately 60% over the last five years. That means the stock has given back all the gains it made when the company’s COVID-19 vaccine ...

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 (MRNA -1.50%), a beaten-down stock with decent prospects, and Teladoc Health (TDOC -1.02%), one whose fu ...