FDA Delays 'Important' Moderna Vaccine Review: William Blair Says 2025 Growth, '2026 Breakeven Story' Depends On It
Portfolio Pulse from Vandana Singh
The FDA has delayed its review of Moderna's new RSV vaccine, mRNA-1345, citing administrative constraints, with a new expected completion by the end of May 2024. Despite this delay, there are no reported issues regarding the vaccine's safety, efficacy, or quality. Moderna's vaccine showed a decline in effectiveness over time but remains a key part of its growth strategy, with an addressable market of about $10 billion. William Blair maintains a Market Perform rating on Moderna shares, which saw a 2.20% decrease in premarket trading.
May 10, 2024 | 1:27 pm
News sentiment analysis
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POSITIVE IMPACT
GSK's RSV vaccine is mentioned as having a slower decline in effectiveness compared to Moderna's mRNA-1345, potentially positioning GSK more favorably in the RSV vaccine market.
The comparison of vaccine effectiveness could influence investor perception, potentially benefiting GSK by highlighting its vaccine's longer-lasting efficacy compared to Moderna's offering.
CONFIDENCE 75
IMPORTANCE 60
RELEVANCE 50
POSITIVE IMPACT
Pfizer's RSV vaccine is also mentioned for its slower decline in effectiveness compared to Moderna's mRNA-1345, which could enhance Pfizer's competitive position in the RSV vaccine market.
The article's comparison of vaccine effectiveness may positively impact Pfizer's stock by positioning its RSV vaccine as a more durable option than Moderna's, appealing to investors.
CONFIDENCE 75
IMPORTANCE 60
RELEVANCE 50
NEUTRAL IMPACT
The FDA's delay in reviewing Moderna's mRNA-1345 vaccine impacts the company's short-term stock performance, evidenced by a 2.20% drop in premarket trading. However, the absence of concerns over safety, efficacy, or quality, alongside the vaccine's significant market potential, suggests a mixed impact on investor sentiment.
The FDA's delay introduces short-term uncertainty, negatively impacting stock price. However, the long-term outlook remains positive given the vaccine's market potential and the lack of concerns over its approval, balancing the short-term impact.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100