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Novavax (NVAX) FY Earnings Call Presentation
2025-06-11 13:44
Goldman Sachs 46th Annual Global Healthcare Conference June 11, 2025 Cautionary Note Regarding Forward-Looking Statements This presentation includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "may," "will," "believe," "estimate," "forecast," "goal," "project," and other words of similar meaning. These forward-looking statements address various matters including Novavax's corporate strategy and ...
MRNA Stock Down on Withdrawal of FDA Filing for COVID-Flu Combo Shot
ZACKSยท 2025-05-22 15:51
Core Viewpoint - Moderna's shares fell nearly 8% after the company voluntarily withdrew its regulatory filing for mRNA-1083, a combination vaccine for influenza and COVID, following consultation with the FDA [1] Group 1: Regulatory Developments - The withdrawal of the filing was anticipated as the FDA had previously requested additional Phase 3 flu efficacy data [2] - Moderna plans to resubmit the filing later this year after obtaining efficacy data from the ongoing Phase III study of its seasonal influenza vaccine, mRNA-1010, with interim data expected this summer [3] Group 2: FDA Guidance - The FDA recently issued new guidance requiring COVID vaccine manufacturers to conduct randomized, placebo-controlled studies to demonstrate the real-world benefits of yearly COVID vaccine boosters for individuals under 65 [4] Group 3: Clinical Data - The initial FDA filing for mRNA-1083 was based on Phase III study data showing it elicited higher immune responses against influenza and COVID compared to standalone vaccines [5] Group 4: Market Performance - Year-to-date, Moderna's shares have decreased by 38%, contrasting with a 4% decline in the industry [6] Group 5: Competitive Landscape - Other companies, including Novavax, Pfizer, and Sanofi, are also developing COVID-flu combination vaccines [8] - Novavax is conducting a late-stage study comparing its combination vaccine's immunogenicity and safety against separate vaccines, with initial data expected later this year [9] - Pfizer faced setbacks in its combination vaccine program and is currently evaluating adjustments to improve immune responses [10][11] - Sanofi has received fast-track designation from the FDA for two of its experimental combination vaccines, currently in Phase I/II studies [12]