Moderna says the FDA will consider its new flu shot after resolving a public dispute [Yahoo! Finance Canada]
Moderna, Inc. (MRNA)
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Source: Yahoo! Finance Canada
Moderna announced the change Wednesday, about a week after revealing that the FDA's vaccine chief was refusing to review the new vaccine, made with Nobel Prize-winning mRNA technology The dispute centered over a 40,000-person clinical trial that concluded Moderna's new vaccine was more effective in adults age 50 and older than one of the standard flu shots used today. In the FDA's rare “refusal to file” letter, vaccine director Dr. Vinay Prasad faulted the trial for not including another brand specifically recommended for people 65 and older. Moderna publicly objected. It said that while the FDA had recommended that approach, the agency ultimately agreed to the study's design — and that the company shared additional comparison data from a separate trial that used a high-dose shot for older people. Nor did the FDA identify any safety concerns. Still, Moderna said Wednesday that in a compromise, it is seeking full approval for the vaccine's use in adults 50 to 64 and accelerated
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News
- Moderna says the FDA will consider its new flu shot after resolving a public dispute [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- FDA backtracks and agrees to review Moderna mRNA flu vaccine after initial rejection [Fortune]Fortune
- FDA agrees to review Moderna’s mRNA flu vaccine application in a reversal [MSNBC.com]MSNBC.com
- Moderna stock surges as FDA reverses course, agrees to review new flu shot [Yahoo! Finance Canada]Yahoo! Finance Canada
- Moderna (NASDAQ:MRNA) had its price target raised by analysts at The Goldman Sachs Group, Inc. from $36.00 to $41.00. They now have a "neutral" rating on the stock.MarketBeat
MRNA
Earnings
- 2/13/26 - Beat
MRNA
Sec Filings
- 2/13/26 - Form 4
- 2/13/26 - Form 4
- 2/13/26 - Form 4
- MRNA's page on the SEC website