Cautious Outlook on Moderna: Hold Rating Amid Regulatory Developments and Market Uncertainty

William Blair analyst Myles Minter has reiterated their neutral stance on MRNA stock, giving a Hold rating on June 9.

Myles Minter has given his Hold rating due to a combination of factors surrounding Moderna’s recent developments. The FDA’s approval of Moderna’s RSV vaccine, mRESVIA, for at-risk adults aged 18-59 is a significant step forward, aligning its label with Pfizer’s similar vaccine. However, despite this regulatory approval, the current CDC recommendations are more conservative, suggesting vaccination primarily for older adults and high-risk individuals, which may limit the immediate market impact.
Minter also notes that the approval was based on updated regulatory guidance that allows for pivotal trials with biomarker-based endpoints without saline-based placebo controls. While this represents a potential shift in regulatory frameworks, the broader adoption of these recommendations by the CDC is still pending. These factors contribute to a cautious outlook, justifying the Hold rating as the market awaits further clarity on the vaccine’s adoption and its impact on Moderna’s financial performance.