TSX gains after CPI shows US inflation rose 3%
Investing.com -- Moderna Inc. (NASDAQ:MRNA) stock fell 5% in after-hours trading Wednesday following the company’s announcement that its cytomegalovirus (CMV) vaccine candidate failed to meet its primary efficacy endpoint in a pivotal Phase 3 trial.
The vaccine, known as mRNA-1647, showed disappointing efficacy against primary CMV infection in healthy women, ranging from just 6% to 23% depending on the case definition used. As a result, Moderna will discontinue its congenital CMV clinical development program.
"Today’s announcement is disappointing for families and healthcare professionals who have been eagerly awaiting a CMV vaccine to prevent congenital CMV, a leading infectious cause of birth defects," said Stéphane Bancel, Chief Executive Officer of Moderna in a statement.
The Phase 3 trial involved approximately 7,500 women aged 16-40 years from about 300 sites across 13 countries, making it the largest trial assessing the efficacy of a CMV vaccine to date. Despite the setback, the company reported that mRNA-1647 was generally well-tolerated with no safety concerns raised by the Data and Safety Monitoring Board.
Moderna plans to continue evaluating mRNA-1647 in an ongoing Phase 2 trial for bone marrow transplant patients, where the vaccine could potentially suppress disease associated with CMV reactivation.
The company stated that this development will not impact its 2025 financial guidance or its expectation of achieving breakeven in 2028, noting that it had anticipated minimal initial revenue contribution from mRNA-1647 given necessary investments in market building and launch.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.