Moderna's mFLUSIVA Gets August 5 PDUFA Date After Unanimous VRBPAC Vote
MRNA has more than doubled off its 52-week low of $22.28.
Summary
The FDA set an August 5 PDUFA date for Moderna's mRNA flu vaccine mFLUSIVA, following a unanimous VRBPAC vote in June. This is the first confirmation of the action date, putting a near-term catalyst on the calendar. The update comes alongside a Q2 recap that raised 2026 revenue guidance to up to 10% growth and disclosed a cash position of $4.7–$5.2B. Separately, the intisimeran cancer therapy with Merck is advancing, with pivotal melanoma data expected later this year. The norovirus trial setback is already known and weighed on shares last week.
At the time of this announcement, MRNA was trading at $55.15 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $21.8B. The 52-week trading range was $22.28 to $85.60. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.