Moderna Stock Price, News & Analysis

Moderna (NASDAQ: MRNA), a leader in messenger RNA therapeutics, has announced its participation in two upcoming virtual investor conferences on December 1. The NASDAQ 45^th Investor Conference will take place at 9:30 a.m. ET, followed by the Piper Sandler 33^rd Annual Virtual Healthcare Conference at 2:00 p.m. ET. Investors can access live webcasts of both presentations on Moderna's website, where replays will also be available for 30 days. Moderna has significantly advanced in mRNA science, especially in developing COVID-19 vaccines.

Moderna, Inc. (NASDAQ: MRNA) announced that the CDC's Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the use of a booster dose of its COVID-19 vaccine for individuals aged 18 and older, following FDA's Emergency Use Authorization.

This recommendation aims to enhance protection against COVID-19 during the winter months as cases rise. Moderna's CEO, Stéphane Bancel, emphasized the importance of this step in combating the pandemic with their mRNA vaccine.

Moderna (MRNA) announced the FDA has extended emergency use authorization for its COVID-19 vaccine booster at a 50 µg dose for all adults aged 18 and older. This decision allows the booster to be administered to individuals who completed primary vaccination with any approved COVID-19 vaccine. The authorization is seen as critical due to rising COVID-19 cases. The FDA's decision was based on data from a Phase 2 study indicating a significant immune response from the booster dose. The CDC will meet to discuss rollout recommendations.

Moderna has initiated a Phase 2/3 clinical trial for its RSV vaccine candidate, mRNA-1345, with plans to enroll approximately 34,000 participants across multiple countries.

RSV is responsible for significant health issues in older adults and young children but currently lacks an approved vaccine. The Company reports an estimated $3 billion annual medical cost due to RSV in the U.S., with about 177,000 hospitalizations and 14,000 deaths among adults 65 and older annually. The trial aims to evaluate the safety and efficacy of mRNA-1345 in adults over 60, supporting future licensure efforts.

Moderna Inc. (Nasdaq: MRNA) has submitted a request for authorization to Health Canada for a 50 µg two-dose series of its COVID-19 vaccine, SPIKEVAX, aimed at children aged 6 to 11. The ongoing Phase 2/3 ‘KidCOVE’ study reports a vaccine efficacy of 100% against symptomatic COVID-19 and 80% for any SARS-CoV-2 infection post-first dose. The firm plans to share these findings with global regulatory bodies to ensure broader protection for this vulnerable age group.

Moderna has received authorization from Health Canada for a booster dose of its COVID-19 vaccine, SPIKEVAX, at a 50 µg dose for individuals aged 18 and older, to be given at least six months after the primary series.

The decision was based on clinical data indicating significant increases in neutralizing antibody levels post-booster, including in adults over 65. The safety profile aligns with previous doses, establishing confidence in the vaccine's continued efficacy against variants.

Moderna announced positive results from the Phase 2 EPICCURE study assessing AZD8601, an mRNA therapeutic for patients undergoing coronary artery bypass grafting (CABG). The study met its primary endpoint of safety and tolerability with 11 participants, revealing numerical improvements in heart failure endpoints, including increased left ventricular ejection fraction (LVEF). All treated patients maintained healthy NT-proBNP levels at follow-up. This data reinforces the potential of AZD8601 for advancing treatment options in heart failure and warrants further exploration in larger studies.