Core Insights - Moderna announced positive preliminary immunogenicity data for the 2025-2026 formula of mNEXSPIKE, targeting the LP.8.1 variant of SARS-CoV-2 [1] - The vaccine demonstrated a greater than 16-fold increase in LP.8.1-neutralizing antibodies across age groups [1] Company Summary - The ongoing Phase 4 clinical trial evaluates the safety, tolerability, and immunogenicity of the 2025-2026 formula of mNEXSPIKE [1] - The vaccine showed strong immune responses against the top circulating COVID-19 strains [1] Age Group Analysis - The data indicates a significant increase in neutralizing antibodies in individuals aged 12 to 64 with underlying conditions and all adults aged 65 and older [1]

Core Insights - Moderna, Inc. is recognized as one of the top AI-powered biotech stocks to consider for investment [1] - The company specializes in mRNA therapeutics and vaccines, with a focus on expanding its pipeline beyond COVID-19 [2] Company Overview - Moderna, Inc. is based in Cambridge and is a leader in mRNA technology, particularly known for its COVID-19 vaccine [2] - The company is diversifying its vaccine offerings to include influenza, RSV, CMV, Zika, and combination vaccines, as well as mRNA therapeutics for oncology, rare diseases, and cardiovascular conditions [2] - Moderna operates globally, with manufacturing facilities in the U.S. and Europe, and utilizes strategic alliances and technology transfers to enhance its operations [2] Market Challenges - In September 2025, Moderna's stock experienced a nearly 7% decline due to reports linking COVID-19 vaccines to approximately 25 child deaths, which raised investor concerns despite the lack of scientific consensus [3] - Policy changes, such as Florida's removal of vaccine mandates, have further complicated near-term demand forecasts for the company [3] Commitment to Safety - The company emphasizes transparency and scientific rigor, citing that over a billion doses of its vaccines have been administered globally, which supports public trust and regulatory engagement [4] Innovation and Technology - Moderna is advancing its mRNA applications beyond COVID-19, integrating AI and machine learning into its R&D pipeline to enhance mRNA design, optimize vaccine formulations, and predict immune responses [5] - This combination of scientific rigor and technological innovation positions Moderna favorably among biotech stocks that are adapting to future healthcare needs [5]

Meanwhile, an RFK Junior back vaccine panel now pushing for new restrictions on a combination shot for children, changing the current recommendations that allow children under four to receive the MMR vaccine. And this morning, uh the uh hepatitis B vaccine vote also was put off. They cited a lack of data, a vote expected later, also on COVID shot recommendations.All right, let's try and make sense of all this. Missouo healthcare sector strategist Jared Holles joins us here at Post 9. I guess from an investo ...

Core Viewpoint - Moderna has reached an agreement to resolve patent litigation with Alnylam Pharmaceuticals regarding the delivery technology used in its COVID-19 vaccine, which Alnylam claimed infringed its patent rights [2]. Group 1 - The litigation involved allegations from Alnylam Pharmaceuticals against Moderna concerning the delivery technology utilized in the COVID-19 vaccine [2]. - Court filings indicate that the two companies have come to a resolution regarding the patent dispute [2].

Core Insights - Moderna's shares increased by 4% following the announcement of positive preliminary immunogenicity data from a phase IV study of its updated COVID-19 vaccine, Spikevax, targeting the LP.8.1 variant [1][6] - The phase IV study demonstrated that the 2025-2026 formula of Spikevax resulted in an average increase of over 8-fold in neutralizing antibodies against the LP.8.1 variant across various age groups, with a safety profile consistent with previous studies [2][6] - The FDA approved updated COVID-19 vaccines from Moderna, Pfizer/BioNTech, and Novavax for the 2025-26 vaccination season, specifically targeting the LP.8.1 strain [4] Company Performance - Year-to-date, Moderna's shares have decreased by 40.3%, contrasting with the industry's growth of 2.8% [3] Regulatory Approvals - The FDA approved Moderna's Spikevax for individuals aged 6 months to 64 years with at least one high-risk condition, and a next-generation version called mNexspike for those aged 12 to 64 years [7] - Pfizer/BioNTech's Comirnaty was approved for at-risk individuals aged 5 years and older, showing a 4-fold increase in neutralizing antibodies against the LP.8.1 variant in a phase III study [8] - Novavax's Nuvaxovid was approved for at-risk individuals aged 12 to 64 years, being the only non-mRNA-based vaccine currently available [9]

Market Overview - U.S. markets experienced a slight decline, with the Dow Jones Industrial Average falling approximately 0.3% to 45,757.90, the S&P 500 decreasing 0.1% to 6,606.76, and the Nasdaq dipping 0.07% to 22,333.96 [1] Nio Inc. (NIO) - Nio's stock surged by 8.17%, closing at $7.02, with an intraday high of $7.09 and a low of $6.48; the 52-week range is $7.71 to $3.02 [2] - The stock's rise followed UBS's upgrade from Neutral to Buy, with a price target increase from $6.20 to $8.50 [2] - Nio's shipment of a new model to dealers contributed to the positive momentum [2] Rivian Automotive, Inc. (RIVN) - Rivian's shares climbed 5.29%, ending the day at $14.32, with a high of $14.65 and a low of $13.73; the 52-week range is $17.15 to $9.50 [3] - The increase is attributed to Rivian's announcement of a new facility in Georgia, marking a significant step in their electric vehicle production [3] Moderna Inc. (MRNA) - Moderna's stock rose by 4.02%, closing at $24.84, with a day's high of $25.63 and a low of $23.91; the 52-week range is $75.37 to $23.15 [4] - This uptick followed the release of preliminary data showing an eight-fold increase in antibodies with their updated Spikevax formula targeting the LP.8.1 variant of SARS-CoV-2 [4] Meta Platforms Inc. (META) - Meta's shares increased by 1.87%, closing at $779, with an intraday high of $781.36 and a low of $765.10; the 52-week range is $796.25 to $479.80 [5] - The rise was influenced by a leak revealing Meta's next-generation smart glasses, described as a "game changer" by analyst Ross Gerber [5] BitMine Immersion Technologies Inc. (BMNR) - BitMine's stock rose by 5.31%, closing at $55.93, with a high of $57.01 and a low of $50.90; the 52-week range is $161 to $3.20 [5] - The increase follows BitMine's report of holding over 2.15 million Ethereum tokens, making it the world's largest Ethereum treasury company [5] Rivian's Performance Metrics - Rivian has a Momentum ranking in the 60th percentile and a Growth ranking in the 24th percentile, compared against Tesla and Nio [6]

Group 1 - Pfizer and Moderna reaffirmed the effectiveness and safety of their mRNA-based COVID vaccines through new clinical trial data [4] - The announcement follows President Donald Trump's call for vaccine makers to justify their success earlier this month [4]

Core Insights - The 2025-2026 formula of Spikevax has shown a greater than 8-fold increase in LP.8.1-neutralizing antibodies across various age groups [1] Company Summary - Moderna, Inc. announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikevax, which targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19 [1] - The data comes from an ongoing Phase 4 clinical trial assessing the safety, tolerability, and immunogenicity of the new formula [1] Clinical Findings - The clinical findings indicate that individuals aged 12 to 64 years with at least one underlying condition that increases the risk for severe COVID-19 outcomes, as well as all adults aged 65 and older, experienced an average of greater than 8-fold increase in neutralizing antibodies against the LP.8.1 variant [1]

Core Insights - Moderna Inc. (MRNA) stock dropped 7% following a report linking the deaths of 25 children to COVID-19 vaccines, resulting in a year-to-date decline of almost 45% [2] - MRNA's performance is being compared to its peers to assess whether its decline is an outlier or part of a broader trend [5] Financial Performance - MRNA's operating margin is -107.1%, the lowest among its peers, while Pfizer (PFE) has an operating margin of 26.1% [8] - MRNA's last-twelve-month revenue growth is -38.8%, underperforming compared to PFE, Alnylam Pharmaceuticals (ALNY), Sarepta Therapeutics (SRPT), AbbVie (ABBV), and Amgen (AMGN) [8] - Over the past year, MRNA's stock has decreased by 66.3% and currently trades at a price-to-earnings (P/E) ratio of -3.1, indicating a loss [8] Competitive Context - MRNA has 44 programs, including 26 clinical trials across various therapeutic areas, which include infectious diseases and immuno-oncology [4] - The recent performance of MRNA, including a 12.6% decline over the last month, raises questions about its valuation and fundamentals in comparison to its competitors [5][8]

Core Insights - Shares of major COVID-19 vaccine manufacturers, including Moderna, BioNTech, Pfizer, and Novavax, experienced declines following reports linking COVID-19 vaccines to the deaths of 25 children [1][6][10] Regulatory Developments - Health officials are reportedly using data from the Vaccine Adverse Event Reporting System (VAERS) to establish a connection between COVID-19 vaccines and pediatric deaths, although VAERS data does not confirm causation [2][3] - The CDC advisory committee is set to meet on September 18-19, 2025, to review vaccine safety, effectiveness, and clinical necessity, which may influence future vaccine recommendations and insurance coverage [5][10] Market Impact - Following the news, Moderna and BioNTech shares fell over 7%, while Pfizer and Novavax saw declines of nearly 4%, indicating investor concerns over regulatory scrutiny and its potential impact on vaccine demand [6][10] Leadership and Policy Changes - The current leadership at the Department of Health and Human Services, particularly Secretary Robert F. Kennedy Jr., known for his vaccine skepticism, has raised concerns about the influence of political factors on public health decisions [7][8] - Recent changes in the CDC advisory committee and the resignation of a senior FDA vaccine official have further fueled worries regarding the independence of public health decision-making [8] Long-term Challenges - Companies like Moderna, Pfizer, BioNTech, and Novavax are already facing declining COVID-19 revenues, and the potential narrowing of vaccine coverage recommendations poses additional long-term challenges [9]