CX-038839 Omicron (XBB.1.5)

Moderna faces challenges with COVID and RSV vaccine sales, adjusting financial reporting and strategy. Despite Spikevax outperforming expectations, the company plans to cut R&D spending and focus on 10 new product approvals, including a next-gen COVID vaccine, aiming for operational efficiency and market adaptation.

Moderna's RSV vaccine, mResvia, approved by FDA for adults 60+, shows 78.7% efficacy at 3.7 months, slightly lower than competitors. Despite a slight share dip, it offers convenience and no GBS risk. Awaiting CDC endorsement, it aims for significant market share, with $1.5B revenue projected by 2033.

13 cases of Long COVID treated with nirmatrelvir/ritonavir showed varied outcomes. Some patients experienced significant symptom improvement, including reduced fatigue, better cognitive function, and less PEM, while others saw minimal or temporary benefits. Side effects and symptom recurrence were noted, with some patients achieving a better baseline post-treatment.

The U.S. pharma industry's public reputation stabilized at 43% positive after fluctuating during the pandemic. With Robert F. Kennedy Jr. potentially leading HHS, the industry faces a possibly hostile administration. Pharma execs argue for data-driven debates to counter anti-vaccine sentiments, emphasizing the importance of maintaining public trust in science and the FDA.

H.C. Wainwright's Ed Arce maintains Buy rating on Arcturus Therapeutics (ARCT) with $63 target, citing promising COVID-19 vaccine advancements, EMA recommendation for Kostaive, and robust pipeline. Canaccord Genuity also maintains Buy with $74 target.

Moderna faces challenges with a 60% drop in share value year-to-date. Despite $4 billion R&D cuts by 2028, investors predict losses. Moderna's market cap dropped to $17 billion from $181 billion in 2021. Despite positive news, stock prices continued to decline. Moderna plans to launch 10 products by 2027, cutting $1.1 billion from the annual budget. FDA detected severe side effects in Moderna's RSV vaccine trials. Moderna's stock fell over 8% due to Robert F. Kennedy Jr.'s nomination to head HHS. Jefferies analysts anticipate Phase III data for Moderna's cytomegalovirus vaccine could impact stock movement.

COVID-19 vaccination is crucial for public health, reducing hospitalization and death. Vaccines include mRNA, inactivated, viral vector, and protein subunit types. Eligibility starts at 6 months, with specific doses for different age groups. The government provides mRNA vaccines for additional boosters, emphasizing timely vaccination for protection against variants like JN.1.

The ABPI updated its code of practice, with changes including mandatory disclosure requirements and a new PMCPA procedure. The PMCPA took action against Moderna for breaching the code, highlighting the importance of self-regulation in maintaining public trust.

EMA approves third anti-COVID-19 vaccine dose for immune-compromised individuals, with Pfizer and Moderna vaccines recommended 28 days post-second dose. Studies indicate increased antibody production, though direct protection evidence is lacking. EMA continues monitoring for efficacy and safety, with booster doses for general population considered 6 months post-second dose.

Moderna's Q3 COVID-19 vaccine sales exceeded expectations at $1.8B, but full-year guidance remains unchanged, suggesting a potential decline in Q4. mResvia, Moderna's RSV vaccine, generated $10M in revenue, significantly below projections. Moderna plans to cut R&D expenses by 20% and prioritize investments in new vaccines and rare disease drugs.