Core Insights - Moderna's Phase 3 trial for mRNA-1647, an investigational CMV vaccine, did not meet its primary efficacy endpoint, failing to prevent CMV infection in seronegative women aged 16-40 [1][3] - The company will discontinue its congenital CMV clinical development program following the trial results [2] - Vaccine efficacy against primary CMV infection was significantly below expectations, ranging from 6% to 23% [3] Company Statements - Stephen Hoge, president of Moderna, expressed disappointment over the trial's failure, highlighting the ongoing need for a vaccine against congenital CMV [4] - Despite the setback, Moderna will continue to explore mRNA-1647's potential in high-risk patients through an ongoing Phase 2 study [4] - The Data and Safety Monitoring Board raised no safety concerns regarding mRNA-1647 [5] Financial Outlook - Moderna does not expect the trial results to impact its 2025 financial guidance or its goal of achieving breakeven by 2028 [5] - The company anticipated minimal initial revenue from mRNA-1647, projecting it to be cash flow negative in 2028 [5] Market Reaction - Following the news, Moderna's stock price fell by 4.15% to $25.74 in premarket trading [7] - Analysts from William Blair view the trial's failure as an incremental setback, maintaining a Market Perform rating for the company [6]