FDA Staff Backs Moderna Flu Vaccine Data for Older Adults
MRNA has more than doubled off its 52-week low of $22.28.
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.