FDA Staff Backs Moderna Flu Vaccine Data for Older Adults
Summary
FDA staff reviewers have indicated that data may support the effectiveness of Moderna's mFlusiva flu vaccine in adults 65 years and older, noting superior efficacy against a standard flu vaccine in adults 50 and older. This positive preliminary assessment follows Moderna's announcement of an August 5 PDUFA date for the mRNA-1010 vaccine and prior news in May detailing its superior performance against GSK's flu shot in late-stage trials. The FDA staff's endorsement significantly de-risks the upcoming regulatory decision, signaling a strong likelihood of approval for a key product targeting a large demographic. Investors will now focus on the August 5 PDUFA date for the final regulatory outcome.
At the time of this announcement, MRNA was trading at $52.51 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $20.7B. The 52-week trading range was $22.28 to $59.55. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: Reuters.