Economic Indicators - US MBA mortgage applications fell by -12.7% in the week ended September 26, with the purchase mortgage sub-index down -1.0% and the refinancing sub-index down -20.6% [1] - The September ISM manufacturing index rose +0.4 to a 7-month high of 49.1, exceeding expectations of 49.0 [6] - The September ADP employment change unexpectedly fell by -32,000, marking the largest decline in 2.5 years, while August was revised lower to -3,000 from +54,000 [5] Market Reactions - Stocks initially moved lower due to the US government shutdown, but later recovered, with the S&P 500 and Nasdaq 100 reaching new all-time highs [2][4] - The dollar index fell to a one-week low, while gold prices climbed to a record high amid risk-off sentiment [2] - Rising corporate earnings expectations are a bullish backdrop for stocks, with over 22% of S&P 500 companies providing guidance for Q3 earnings that are expected to beat analysts' expectations [8] Sector Performance - Pharmaceutical stocks rallied, with AstraZeneca closing up more than +9% and Eli Lilly up more than +8%, driven by hopes from Pfizer's deal with the US government [15] - Chipmakers and AI-infrastructure stocks also saw gains, with Super Micro Computer closing up more than +9% and Micron Technology up more than +8% [16] - Grocery retailers declined after Amazon announced a new private-label food brand, leading to Dollar Tree and Dollar General closing down more than -4% and -3% respectively [22] Upcoming Economic Data - Weekly initial unemployment claims are expected to increase by +7,000 to 225,000, and August factory orders are expected to rise by +1.4% month-over-month [9] - September nonfarm payrolls are anticipated to increase by +51,000, with the unemployment rate expected to remain unchanged at 4.3% [9]

RT Giacomo Tognini (@giacomotognini)1/ Shares in Moderna and BioNTech have imploded since their 2021 peaks, shaving billions of dollars from their founders’ fortunes. Growing anti-vax hysteria and RFK Jr.’s FDA will likely make the situation even worse.Read at @Forbes:https://t.co/xWQY221wea ...

Core Viewpoint - The FDA is considering an independent evaluation of DNA levels in COVID-19 vaccines due to concerns raised about potential contamination and safety issues related to residual DNA found in the vaccines [1][4][12]. Group 1: FDA and CDC Actions - The FDA's advisory panel discussed the potential for higher-than-allowed levels of DNA in COVID-19 vaccines and the implications of mRNA persistence in the body [4][12]. - The CDC's vaccine advisory panel unanimously recommended rolling back COVID-19 vaccine recommendations amid growing concerns [4][12]. - The FDA has withdrawn the emergency authorization for COVID-19 vaccines but approved them for limited groups, indicating a shift in focus towards investigating safety concerns [12][13]. Group 2: Scientific Concerns - Concerns have been raised about the presence of residual DNA in Pfizer and Moderna vaccines, with some studies indicating levels exceeding FDA regulatory limits [8][18]. - Experts have warned that residual DNA could integrate into the human genome, potentially leading to autoimmunity issues [7][18]. - The FDA has stated that no safety concerns related to the residual DNA have been identified despite the ongoing discussions [8][12]. Group 3: Company Responses - Moderna and Pfizer representatives defended their testing methods, claiming that their assays are specific for residual DNA and validated to meet FDA standards [16][17]. - The companies acknowledged the presence of residual DNA but asserted that it was within acceptable limits as defined for their specific products [17][18]. - A Moderna executive criticized outside testing methods as flawed, emphasizing the company's adherence to industry-standard testing protocols [16]. Group 4: Advisory Panel Recommendations - The advisory panel recommended that individuals consult healthcare providers before receiving COVID-19 vaccines, considering personal health factors [20]. - Members suggested that the CDC should enhance information about potential risks associated with prolonged exposure to vaccine components, including spike proteins and mRNA [21].

PresentationCourtney BreenSanford C. Bernstein & Co., LLC., Research Division Fantastic. Hi, everyone. It's great to have you here today. Thank you so much for joining us. I am privileged to be sharing the stage with Rose Loughlin here from Moderna. For those of you who do not know me, my name is Courtney Breen. I cover the U.S. large cap names here at Bernstein. And we're hoping to have a bit of a conversation, particularly into the oncology portfolio at Moderna today. We're going to start first, though, ...

Summary of the Conference Call Company and Industry - **Company**: Moderna - **Industry**: Oncology and mRNA-based therapeutics Key Points and Arguments 1. **Oncology Portfolio Overview**: Moderna is advancing a diverse oncology portfolio utilizing multiple therapeutic approaches and platform technologies to address various cancer types and stages [5][27] 2. **Individualized Neoantigen Therapy (INT)**: INT is a personalized therapy that identifies patient-specific neoantigens from tumor samples, showing promising results in combination with Keytruda, reducing recurrence risk by 49% and distant metastasis risk by 62% [6][7] 3. **Phase Three Study**: A phase three study in adjuvant melanoma combining INT with Keytruda has completed enrollment, with data expected in 2026 [9] 4. **Expansion of INT Development**: INT is being tested across multiple tumor types, including non-small cell lung cancer and bladder cancer, with various combinations [10] 5. **Off-the-Shelf Cancer Antigen Therapies**: Moderna is developing off-the-shelf therapies like mRNA-4359, which targets shared antigens in cancer cells, aiming for broader applicability across different cancer types [11][12] 6. **T Cell Engagers**: The company is developing T cell engagers that guide immune responses towards cancer cells, addressing tumor heterogeneity and immune dysfunction in advanced cancers [18][19] 7. **Cell Therapy Enhancers**: Moderna is exploring in vivo cell therapies to enhance the efficacy of existing CAR-T therapies, potentially improving outcomes in solid tumors [25][26] 8. **Partnerships**: Moderna has a 50/50 partnership with Merck for INT and collaborates with Immatics for T cell receptor development, leveraging external expertise to enhance their capabilities [60][61] 9. **Future Catalysts**: Key upcoming data releases include the five-year follow-up for INT in 2026 and additional data from ongoing studies in various cancer types [39][40] 10. **Competitive Landscape**: Moderna is monitoring competitors like BioNTech and IO Biotech, assessing their data to inform and de-risk its own development strategies [51][52] Other Important Content 1. **Safety and Tolerability**: The safety profiles of INT and other therapies are encouraging, with low-grade adverse events reported [7][14] 2. **Translational Data Importance**: Translational data from early studies will guide future development and inform the potential clinical benefits of therapies [64] 3. **Diverse Therapeutic Approaches**: Moderna's strategy involves a toolkit approach, tailoring therapies based on cancer stage and patient needs, from preventive to advanced settings [30][31] 4. **Market Opportunities**: The company sees potential in both solid and liquid tumors, with a focus on enhancing immune responses in challenging environments [36][44] 5. **Long-term Vision**: Moderna aims to significantly impact patient lives through its diverse oncology portfolio, leveraging its mRNA platform technology [67]

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mRNA-4157/V940 in combination with KEYTRUDA - At ~3 years of follow-up, the recurrence-free survival rate of mRNA-4157/V940 in combination with KEYTRUDA was 74.8%, compared to 55.6% for KEYTRUDA alone[12] - At a median planned follow-up of 34.9 months, mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 49%[14] - At ~3 years of follow-up, mRNA-4157/V940 in combination with KEYTRUDA demonstrated a 62% reduction in the risk of developing distant metastasis or death compared to KEYTRUDA alone[17] Safety and Tolerability of mRNA-4157/V940 - In the adjuvant melanoma trial, any treatment-related adverse event occurred in 100% of patients (n=104) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 25% of patients[18] - Serious adverse events occurred in 14.4% of patients (n=15) receiving mRNA-4157 (V940) + pembrolizumab[18] - Immune-related adverse events occurred in 37.5% of patients (n=39) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 10.6% of patients[18] - 94.2% of patients (n=98) experienced mRNA-4157 (V940)-related adverse events, with 33.7% Grade 1, 49% Grade 2, and 11.5% Grade 3[18] Development Programs - The Phase 3 study for adjuvant melanoma with mRNA-4157/V940 is fully enrolled[21, 22] - mRNA-4359 is ongoing in Phase 1/2 study; now enrolling Phase 2 with additional indications planned[27] - mRNA-2808 is in Phase 1 development[41] - mRNA-4203: IND open, in combination with Immatics' IMA203[49]

Core Insights - The Moderna Innovation and Technology Centre (MITC) in Harwell, Oxfordshire is now fully operational, licensed to supply British-made COVID-19 vaccines to the UK population [1] - This facility is a key component of Moderna's ten-year strategic partnership with the UK Government, aimed at enhancing health resilience and promoting economic growth [1] - The MITC will produce mRNA respiratory vaccines for the UK public, supporting the National Health Service (NHS) seasonal vaccination programs [1]

Group 1 - The analyst had a sell call on Moderna (MRNA) in April 2025, which was considered bold at the time due to the significant correction and perception of limited further downside [1] - The analyst has over 20 years of experience in quantitative research, financial modeling, and risk management, focusing on equity valuation, market trends, and portfolio optimization [1] - The analyst previously served as Vice President at Barclays, leading teams in model validation, stress testing, and regulatory finance, indicating a strong background in both fundamental and technical analysis [1] Group 2 - The analyst collaborates with a research partner, who is also their spouse, to co-author investment research, combining complementary strengths for high-quality insights [1] - The research approach emphasizes rigorous risk management and a long-term perspective on value creation, with a focus on macroeconomic trends, corporate earnings, and financial statement analysis [1] - The goal is to provide actionable ideas for investors aiming to outperform the market [1]

Core Insights - Moderna's updated COVID-19 vaccine formulation has shown a strong immune response in all adults aged 65 and older, as well as in individuals aged 12 to 64 with at least one underlying health condition [1] Company Summary - The company has focused on enhancing its vaccine formulation to improve immune responses among older adults and those with underlying health issues [1]